STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5515-F-402 |
Device Problems
Sticking (1597); Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 04/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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The triathlon #4 rt femoral implant stuck in the package, both in the ist layer and second layer of the sterile package.
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Manufacturer Narrative
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An event regarding packaging issue involving a triathlon ps fem component, cemented was reported.The event was confirmed.Method and results: device evaluation and results: it has abrasions in the skin pack of the packaging.It also has creases in the rounded part where the femoral component would sit.The seals of the skin pack and the outer package appeared to show no signs of (b)(6) seal issues.Medical records received and evaluation: not performed as no medical records were returned.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the skin packaging sticking to the femoral component is an inherent problem.The nature of the molding of the sheet of plastic to the femoral component will be tight to secure the product from movement during transportation.This may cause the product to be difficult to remove from its skin pack.
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Event Description
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The triathlon #4 rt femoral implant stuck in the package, both in the ist layer and second layer of the sterile package.
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Search Alerts/Recalls
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