US20150230926A1 - Method and device for reducing implant contamination from handling - Google Patents

Abstract

An orthopedic implant has a removable handling cover coupled thereto which includes a thin-walled layer extending over a grasping portion of the outer surface. An outer container can sealingly house the orthopedic implant within a sterile environment and support the orthopedic implant in an orientation that presents the handling cover for grasping. A surgeon can manually grasp, handle and manipulate the implant into an implantation position, and remove the handling cover from the implant during implant surgery, and without the need to directly contact any surface of the orthopedic implant itself. Related methods of providing such an implant assembly and of reducing infection from contamination during implantation surgery are also disclosed.

Description

FIELD
• The present disclosure relates to methods and devices for reducing implant contamination from handling.
BACKGROUND
• This section provides background information related to the present disclosure which is not necessarily prior art.
• Infection remains a devastating complication of total joint replacement, affecting about one to four percent, of all primary procedures. Infection can occur by contamination at the surgical site at the time of the procedure or by hematogenous seeding. Possible routes for contamination at the time of surgery include the surgical team touching the implant or tissues within the operative site with contaminated gloved hands or instruments. Instruments can become contaminated because the cleaning procedures were not adequate after prior use or because the instruments were contaminated during the current surgery.
• In a recent study, Davis showed that 63 percent of primary hip and knee arthroplasties had contamination in the field of operation (Davis 1999). Davis' study also showed that about 29 percent of gloves used in the primary hip and knee procedures for preparation were found to be contaminated. In another study, Maathuis showed that 30 percent of broaches used in total hip arthroplasty had bacterial contamination at the end of the procedure (Maathuis 2005).
• One significant source of such contamination is when packages containing sterile implantable devices are opened in the operating room, it is almost always necessary to manually remove the implant from the packaging. In many cases, removal of the implant from the package requires handling of the implant with potentially contaminated gloves or implements, which can transfer contamination to the surface of the implant.
SUMMARY
• This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
• Disclosed is an orthopedic implant assembly providing reduced contamination from handling that can include an orthopedic implant having an outer surface including a grasping portion and a bone-facing portion. A removable handling cover is coupled to the orthopedic implant and includes a thin-walled layer extending over the grasping portion of the outer surface. An outer container can sealingly house the orthopedic implant within a sterile environment and support the orthopedic implant in an orientation that presents the handling cover for grasping upon opening the outer container. The removable handling cover can provide a removable grasping portion for manually grasping, handling and manipulating the implant into an implantation position with the bone-facing surface facing an adjacent bone during implant surgery without the need to directly contact any of the outer surface of the orthopedic implant. And the removable handling cover can be removable during surgery after the implant is moved into the implantation position.
• Also disclosed is a method of providing an orthopedic implant with reduced contamination from handling. The method can include covering a grasping portion of the orthopedic implant with a handling cover comprising a thin-walled, protective layer that is removable from the implant during implantation surgery. The method can also include supporting the orthopedic implant in an orientation within a container that presents the removable, thin-walled, protective layer to a user upon opening the container, and sealing the orthopedic implant in a sterile condition within a sterile environment of a container.
• A method of reducing infection from contamination of an orthopedic implant during surgery is additionally disclosed. The method can include opening a sterile container housing the orthopedic implant to present a removable thin-walled layer selectively covering a handling portion of the implant for easy grasping. The method can additionally include handling and manipulating the implant into an implantation position by manually grasping the presented removable thin-walled layer, and removing the removable thin-walled layer prior to closure during the implantation procedure.
• Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
DRAWINGS
• The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.
• FIG. 1 is a perspective view of a femoral component of a knee implant, including a handling cover.
• FIG. 2 is a side elevation view of a tibial component of the knee implant ofFIG. 1, including a handling cover.
• FIG. 3 is a side elevation view of a tibial component of the knee implant ofFIG. 2, including an alternative handling cover.
• FIG. 4 is a perspective view of another polyethylene component of the knee implant ofFIG. 1, including an alternative handling cover.
• FIG. 5 is a perspective view of a femoral stem component of a hip implant, including a handling cover.
• FIG. 6 is a perspective view of a femoral head component of the hip implant ofFIG. 5, including a handling cover.
• FIG. 7 is a perspective view of an acetabular component of the hip implant ofFIG. 5, including a handling cover.
• FIG. 8 is a perspective view of an acetabular liner component of the hip implant ofFIG. 5, including a handling cover.
• FIG. 9 is a perspective view of a femoral component of a knee implant, including a handling cover, in a sterile package.
• FIG. 9A is a perspective view of the femoral component and handling cover ofFIG. 9.
• FIG. 10 is a side elevation view of a tibial component of the knee implant ofFIG. 9, including a handling cover, in a cross-sectioned sterile package.
• FIG. 11 is a perspective view of a femoral stem component of a hip implant, including a handling cover, in a sterile package.
• FIG. 11A is a partial axial cross sectional view of a trunnion and shoulder portion of the femoral stem component, including the handling cover, ofFIG. 11.
• FIG. 11B is a partial transverse cross sectional view of the trunnion of the femoral stem component, including the handling cover, ofFIG. 11.
• FIG. 12 is a side elevation view of a femoral head component of the hip implant ofFIG. 11, including a cross-sectioned handling cover and sterile package.
• FIG. 13 is a side elevation view of a tibial component of a knee implant with a sterile package that also comprises a portion of the thin-walled handling cover.
• FIG. 14 is a perspective view of a polyethylene component of the knee implant ofFIGS. 9 and 10, including a spring member handling cover.
• FIG. 15 is a perspective view of a femoral component for a knee implant including a handling cover with an extending handle.
• Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
DETAILED DESCRIPTION
• Example embodiments will now be described more fully with reference to the accompanying drawings.
• FIGS. 1-4 illustrate various orthopedic knee implant components that can be used together, each including a handling or grasping cover. Specifically,FIG. 1 illustrates afemoral component10 of the orthopedic knee implant. Thehandling cover12 of thefemoral component10 comprises a compliant film that covers agrasping portion14 of the outwardly facing surface of thefemoral component10.
• In this embodiment, thegrasping cover12 film extends over thegrasping portion14, which is at least a portion of the non-bone facing surface, including the sides of thefemoral component10. Thus, a surgeon can readily grasp, manipulate and place thefemoral component10 into an implantation position with thebone facing surface16 adjacent the femoral bone while the surgeon only directly contacts or touches thegrasping cover12. In other words, there is no need to directly contact any portion of anysurface14 or16 of thefemoral component10 during implantation surgery.
• A posteriorly-facingportion13 of theouter surface14 of thefemoral component10, above dottedline18 for example, can lack anyhandling cover12 film. Alternatively, asecondary portion20 of thehandling cover12 film above dottedline18 can be separately removed prior to positioning thefemoral component10 in an implantation position. After thefemoral component10 is in position, the remainder, or primary portion of thehandling cover12 film can be removed from thegrasping surface14 of thefemoral component12.
• The handlingcover12 film can include atab22 which the surgeon can grasp to aid removal of thefilm12. The handlingcover12 film can comprise a thin film coated with adhesive to adhere to thegrasping surface14 of thefemoral component10. The handling cover film can comprise a naturally adhering film, for example, held in place with static electricity. The adheredhandling cover12 film can also comprise a shrink wrap film. Other mechanisms can be used to adhere ahandling cover12 film to the implant. For example, anelasticized member34 at an opening of athin film member26′ (similar to a shower cap) can be used as illustrated inFIG. 3.
• The handling cover12 film can be formed directly on the implant component. For example, the grasping portion of thefemoral component10 can be coated with a material that forms a film on the surface and that is removable during implantation surgery as described herein. For example, the coating material can be printed or painted on the graspingsurface14 of thefemoral component10 of the implant to form thehandling cover12 film.
• FIG. 2 illustrates atibial component24 that can be used with the orthopedic knee implant ofFIG. 1. Similar to the discussion above, thetibial component24 includes a thin-walled handling cover26 film over a graspingsurface28. In this embodiment, the graspingsurface28 includes the upwardly facing tibial tray and sides. Here too, there is no handlingcover26 on thebone facing surface30 of thetibial component24, allowing thetibial component24 to be grasped and manipulated into an implantation position adjacent the bone without the surgeon needing to directly contact any portion of thetibial component24. The handling cover26 film can be removed from thetibial component24 after it has been moved into an implantation position.
• As appropriate, cement can be applied to abone opposing surface30 of an implant component, includingtibial component24. The surgeon can grasp and manipulate thetibial implant component24 using thehandling cover26 film. The handling cover26 film can also help insure bone cement does not remain on thetibial component24 in undesired locations. For example, any cement extending onto the handlingcover26 film, can be removed along with removal of thehandling cover26 film.
• FIG. 4 illustrates apolyethylene component46 that can be used with the orthopedic knee implant components ofFIG. 1 and 2 or3. Thepolyethylene component46, includes ahandling cover48. After thehandling cover48 film has been removed from thetibial component24, thepolyethylene component46 can be coupled to the upper surface or tibial tray thereof, opposing thefemoral component10.
• The graspingportion47 andcorresponding handling cover48 film can include only a portion of the sides thereof. For example, the handlingcover48 film can cover the sides and a few millimeters of the top, bottom, or both. In addition, the handlingcover48 can end atedges50 so that a posterior portion of the sides of thepolyethylene component46 is left uncovered. In the illustrated embodiment, the handlingcover48 can extend around approximately 270 degrees of the anterior portion of the side wall. In other words, leaving about 45 degrees on either side of the posterior midpoint of the side wall uncovered by the handlingcover48.
• In addition, a separate handling cover film (not shown, but similar to20 ofFIG. 1) can be provided over the upper surface of thepolyethylene component46. Thus, the separate handling cover film can provide additional protection, and removed prior to positioning thepolyethylene component46 into an implantation position.
• Thepolyethylene component46 can be grasped and manipulated into an implantation position via thehandling cover48 film and without the surgeon needing to directly contact with any portion of thepolyethylene component46. A surgeon can grasp extendingtabs53 to peel thehandling cover48 film from thepolyethylene component46 after it is in an implantation position. Extending or graspingtabs53 can be provided as an extension of the film member itself as illustrated, or as an extending string member (not shown), or as another extending or grasping tab member.
• FIGS. 5-8 illustrates various orthopedic hip implant components.FIG. 5 illustrates afemoral stem component54 of the orthopedic hip implant. A graspingportion56 can include thetrunnion59,shoulder region60 and neck therebetween. The graspingportion56 is covered by ahandling cover58 film. In contrast, the bone facing or opposingportion61 of thestem component54 might not include ahandling cover58, or can have a handling cover (not shown) that can be removed prior to manipulating thefemoral stem component54 into an implantation position adjacent the bone by grasping thehandling cover58 film and without directly contacting any surface of thefemoral stem component54.
• The handling cover58 of this embodiment includes a frangible tear line or cut-through line providing a separation line identified by dottedline62. For example, a surgeon can grasp pulls the extending graspingtabs64 to remove thehandling cover58 film in portions along separation line indicated by dottedline62. Thus, the surgeon can peel two halves of thehandling cover film58 from thefemoral stem component54 without directly contacting thefemoral stem component54.
• FIG. 6 illustrates a modular femoral head component66 for use with thefemoral stem component54 ofFIG. 5. The thin-walled handling cover68 film can overlay essentially all of the outer polished surface or grasping portion67 of the femoral modular head component66. In this case a grasping tab69 is illustrated. Any of the previously described grasping tabs (FIGS. 1 and 2), frangible tear lines (FIGS. 3 and 5), strings (FIG. 4 lifting string andFIG. 5 tear string), or combinations thereof, however, can be used. In addition, the thin-walled handling cover68 can include a plurality of any of the above.
• Not only can the handling cover68 enable a surgeon to manipulate the femoral head component66 into an implantation position, but the cover68 can remain on the surface of the femoral head component66 corresponding to the graspingsurface56 while an impact tool is used to seat the femoral head component66 onto thestem component54. In this way, not only is the risk of contamination reduced from direct manual contact by a surgeon's hands, but also from direct contact with an impaction tool (not shown) during the implantation surgery.
• FIGS. 7 and 8 illustrate an acetabular cup component70 and an acetabular liner component72 of the hip implant ofFIG. 5. A handling cover74 film can be provided over the upper surface76 of the acetabular cup component70, including the locking protrusions78, and the interior spherical concave surface80. The handling cover74 film can include cylindrical openings surrounding each of the screw apertures82 on the interior surface80 of the cup70 (simply indicated by dotted lines75). In this way, the acetabular component70 can be grasped and manipulated into an implant position, with the porous outer bone-facing or opposing surface85 adjacent bone, by contacting only the grasping surface84 covered by the handling cover74 film. Screws (not shown) can also be inserted through the apertures82 to fix the acetabular component70 in place in a full and final implantation position. Thereafter, the handling cover74 can be removed.
• After the handling cover74 has been removed from the acetabular component70, the surgeon can grasp and manipulate the acetabular liner component72 into place within the concavity of the acetabular component70. Similar to the acetabular component70, liner72 can include a handling cover86 film over the upper surface88, including the radial outer side surfaces of locking protrusions90. In this example, the handling cover86 is stretched between opposite portions of the upper surface88 to form a generally planar film above the interior spherical concave surface92. The handling cover86 film can be absent from the radial outer sides forming locking recesses94 to enable the acetabular liner72 to be fully seated within the cup70 prior to removing the handling cover86 film during implantation surgery.
• Here too, any of the previously described grasping tabs (FIGS. 1 and 2), frangible tear lines (FIGS. 3 and 5), strings (FIG. 4 lifting string andFIG. 5 tear string), or combinations thereof can form part of the thin-walled handling covers74 and86 or be provided in addition to the handling covers74 and86. In addition, the thin-walled handling covers74 and86 can each include a plurality of any of the above.
• While each ofFIGS. 1-8 illustrate thin-walled grasping covers that all comprise flexible, compliant, or conformable films,FIGS. 9-11 illustrate grasping covers that all comprise thin-walled molded members. It is further noted that each of the embodiments ofFIGS. 1-8 can be housed within a sterile environment of a container as specifically illustrated inFIGS. 9-11.
• FIGS. 9 and 9A illustrate a molded thin-walled handling cover100 for a femoralknee implant component102. The combinedassembly100 and102 is supported within asterile container104 to present the thin-walled moldedhandling cover100 to a surgeon upon opening thetop cover106 of the container. Thus, the surgeon can readily grasp and remove thefemoral component102 and handle and manipulate it into an implantation position by grasping thehandling cover100 over the graspingsurface portion107 of thefemoral component102 without directly touching any surface of the actual implant.
• Thehandling cover100 includes a pair ofprotrusions108 on inner surfaces that engage againstlower edges110 on each side of thefemoral component102. Thus, after the surgeon is done manipulating thefemoral component102, pressure can be applied by the surgeon alongedges114 to release theprotrusions108 from theedges110; facilitating removal of thehandling cover100 from thefemoral component102.
• FIG. 10 illustrates a tibialknee implant component116 which can be used with the component ofFIG. 9, and includes a molded thin-walled handling cover118, in asterile package120. Similar to the above, thesterile package120 supports thetibial component116 in an orientation that presents thegrasping surface122 covered by thehandling cover118 to the surgeon upon opening thepackage120.
• Thehandling cover118 can include one or more discrete projections oredges124 that engage anedge126 of thetibial component116. Similar to edge114 ofFIGS. 9 and 9A, thehandling cover118 can include a flared portion ortab128 or can including an edge that can be pushed to release thehandling cover projections124 from theedge126 of thetibial component116; facilitating removal of thehandling cover118.
• FIG. 14 illustrates a polyethyleneknee implant component160 that can be used with the knee implant components ofFIGS. 9 and 10. A molded thin-walled handling cover162 is formed to extend over a portion of the side wall defining agrasping surface166. Thehandling cover162 can also extend along a periphery of the upper surface indicated bydotted line168 to help minimize any direct contact with the surface of thepolyethylene component160 during, grasping, handling, and manipulation thereof. Thehandling cover162 can be molded as a spring-like member which grasps thesides166 of thepolyethylene component160, but can also be readily removed during implantation surgery after it has been placed in an implantation position. For example, a surgeon can simply grasptab170 and pull in the direction indicated by arrow A, causing spring-like handling cover162 to be removed from thepolyethylene component160.
• FIGS. 11,11A, and11B illustrate afemoral stem component130 of a hip implant, including ahandling cover132. Thefemoral stem component130 is supported in asterile package134 to present thegrasping surface136 covered by thehandling cover132 to the surgeon upon opening thecontainer134 similar to that described above. Thehandling cover132 is molded withprotrusions133 to engage the undercut138 provided by theflats140 of theneck142 of thefemoral stem component130.
• As best seen inFIG. 11B, thehandling cover132 has an oval cross-sectional shape and is molded from a resilient material. Thus, a surgeon can squeeze along the major axis as indicated by arrows A of the oval cross sectional shape of thehandling cover132; causing expansion along the minor axis as indicated by arrows B to allow theprotrusions133 to move past the projection or edge resulting from the undercut138 creating theflats140. In this way, a surgeon can release and remove thehandling cover132 from thefemoral stem component130 after it has been manipulated into an implantation position within the body.
• FIG. 12 illustrates afemoral head component146 of the hip implant ofFIG. 11 within asterile package147 supported in an orientation to present thegrasping surface148 covered by a molded thin-walled handling cover150 to the surgeon upon opening thepackage147.
• Thehandling cover150 can be molded to closely fit the polishedouter surface148 so it is coupled to thehead146 as a result of the reduced diameter adjacent thebase152 of thehead146.Handling cover150 can include a plurality of split lines indicated by dashedline154. For example, two, four, six, or some other number of equally spaced splitlines154 can extend partially up from the bottom edge toward the midpoint of thehandling cover150. Thus, thesplit lines154 can separate and allow the moldedhandling cover150 to be removed from thehead146.
• FIG. 13 illustrates analternative tibial component178, handlingcover180, andsterile container182. In this example, thehandling cover180 is a molded thin-walled member coupled to thetibial component178 via aprotrusion184 engaging against theedge186 of theimplant178. Although a single blister container is illustrated, the sterile container of this or any other embodiment can comprise two or more nested blisters to provide increased assurance of sterility.
• FIG. 15 illustrates afemoral component172 for a knee implant including a thin-walled handling cover174 with an extendinggrasping handle176. As with the packages and the other features associated with the thin-walled handling covers described herein, such agrasping handle176 extending from the thin-walled portion of thehandling cover174 can be provided with any of the embodiments described herein, and can be integrally molded with the molded embodiments.
• Any of the thin film covers described herein can have a visual appearance that makes it immediately apparent that the thin film cover has not been removed from the implant. For example, the thin film cover can comprise a bright color, a printed pattern, or both, causing the thin film cover to visibly stand out against the implant.
• It should further be understood from the above that several orthopedic implant components can be implanted together during a single implantation surgery, and that each one of the components implanted together can be provided as part of an assembly with a thin-walled handling cover, an outer package providing a sterile enclosure, or both.
• The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.
• The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. For example, although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
• The term “implantation position” can encompass the full and final implantation position of the implant within the body, but is not limited to such. Thus, the term “implantation position” can include other positions, such as where a bone opposing surface of an implant is positioned adjacent a corresponding bone, e.g., in a position near the full and final implantation position.

Claims (24)

What is claimed is:

1. An orthopedic implant assembly providing reduced contamination from handling, comprising:

an orthopedic implant having an outer surface including a grasping portion and a bone-facing portion;

a removable handling cover providing a thin-walled layer extending over the grasping portion of the outer surface;

an outer container sealingly housing the orthopedic implant within a sterile environment and supporting the orthopedic implant in an orientation that presents the handling cover for grasping upon opening the outer container;

wherein the removable handling cover provides a removable grasping portion for manually grasping, handling and manipulating the implant into an implantation position with the bone-facing surface facing an adjacent bone during implant surgery without the need to directly contact any of the outer surface of the orthopedic implant, and which removable handling cover is removable during surgery after the implant is moved into the implantation position.

2. The orthopedic implant assembly ofclaim 1, wherein the removable handling cover covers a side of the orthopedic implant and a peripheral portion only of a surface adjacent the side of the orthopedic implant.

3. The orthopedic implant assembly ofclaim 1, wherein the removable handling cover comprises a compliant film conforming over the grasping portion of the outer surface of the orthopedic implant.

4. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises an adhesive film adhered to the grasping portion of the outer surface of the orthopedic implant.

5. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises an naturally adherent film adhered to the grasping portion of the outer surface of the orthopedic implant.

6. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises a material coated on the grasping portion of the outer surface of the orthopedic implant.

7. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises a shrink wrap film.

8. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises an elastic member at an opening, wherein the elastic member forms the compliant film around and captures the orthopedic implant.

9. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises a grasping tab to facilitate removal of the compliant film from the orthopedic implant.

10. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises a separation line to facilitate removal of the compliant film from the orthopedic implant.

11. The orthopedic implant assembly ofclaim 3, wherein the compliant film comprises a bright color, a printed pattern, or both, causing the thin film cover to visibly stand out against the implant.

12. The orthopedic implant assembly ofclaim 1, wherein the removable handling cover comprises a molded member forming the thin walled layer and coupled to the orthopedic implant over the grasping portion of the outer surface.

13. The orthopedic implant assembly ofclaim 12, wherein the handling cover engages an edge of the orthopedic implant to cause the removable handling member to be resiliently coupled to the orthopedic implant.

14. The orthopedic implant assembly ofclaim 12, wherein the handling cover comprises a molded protrusion that cooperates with the edge of the orthopedic implant to cause the removable handling member to be resiliently coupled to the orthopedic implant.

15. The orthopedic implant assembly ofclaim 12, wherein the handling cover and orthopedic implant each comprise components of a snap-fit coupling to couple the handling cover into position over the grasping portion of the outer surface of the orthopedic implant.

16. The orthopedic implant assembly ofclaim 12, wherein the handling cover comprises a curved spring-like configuration to resiliently couple the handling cover to the orthopedic implant.

17. The orthopedic implant assembly ofclaim 12, wherein the molded member comprises a handle portion extending from the thin-walled layer.

18. A method of providing an orthopedic implant with reduced contamination from handling comprising:

covering a grasping portion of the orthopedic implant with a handling cover comprising a thin-walled, protective layer that is removable from the implant during implantation surgery;

supporting the orthopedic implant in an orientation within a container that presents the removable, thin-walled, protective layer to a user upon opening the container;

sealing the orthopedic implant in a sterile condition within a sterile environment of a container.

19. The method ofclaim 18, further comprising, forming the thin-walled protective cover of a compliant film selected from at least one of adhesive film adhered to the grasping portion of the outer surface of the orthopedic implant, an naturally adherent film adhered to the grasping portion of the outer surface of the orthopedic implant, a material coated on the grasping portion of the outer surface of the orthopedic implant, a shrink wrap film, and an elastic member at an opening which forms the compliant film around and captures the orthopedic implant.

20. The method ofclaim 18, further comprising, providing the thin-walled protective layer with at least one of:

a grasping tab to facilitate removal of the compliant film from the orthopedic implant;

a separation line to facilitate removal of the compliant film from the orthopedic implant; and

a bright color, a printed pattern, or both, causing the thin film cover to visibly stand out against the implant

21. The method ofclaim 18, further comprising, providing the thin-walled protective cover as a molded member snap-fit into position over the grasping portion of the outer surface;

further comprising, engaging the molded member with an edge of the orthopedic implant to cause the handling cover to be snap-fit into position over the grasping portion of the outer surface; and

further comprising, providing a protrusion extending from the handling cover and forming the edge as part of an indent provided on the orthopedic implant.

22. A method of reducing infection from contamination of an orthopedic implant during surgery comprising:

opening a sterile container housing the orthopedic implant to present a removable thin-walled layer selectively covering a handling portion of the implant for easy grasping;

handling and manipulating the implant into an implantation position by manually grasping the presented removable thin-walled layer;

removing the removable thin-walled layer prior to closure during the implantation procedure.

23. The method ofclaim 22, wherein removing the removable thin-walled layer comprises at least one of:

peeling the thin walled layer from a surface of the implant;

disengaging an engagement portion of the thin-walled layer from an edge of the implant;

disengaging a snap-fit arrangement coupling the thin-walled member to the implant;

grasping and pulling a tab of the thin-walled layer; and

separating the thin-walled layer along a separation line of the thin-walled layer.

24. The method ofclaim 22, further comprising applying adhesive to orthopedic implant prior to removing the thin-walled layer.

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