STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5510F302 |
Device Problems
Product Quality Problem (1506); Device Packaging Compromised (2916); Compatibility Problem (2960); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2015 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported that upon opening a box labeled triathlon cruciate retaining femoral [right cemented], it was discovered that the inner content did not match the outer label.
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Manufacturer Narrative
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An event regarding a femoral component-labelled pack containing a baseplate involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: the unit carton was returned opened and damaged with no shrinkwrap present.The unit carton contains four product labels detaling a triathlon cruciate retaining femoral, catalogue number 5510-f-302 and lot code aht7l.No outer blister pack was returned.The inner blister pack returned unopened and contained a triathlon primary tibial baseplate, catalogue number 5520-b-300 and lot code amm6k.-medical records received and evaluation: not performed as no medical records were provided.-device history review: the device was manufactured and accepted into final stock on 25-june-2015 with no reported discrepancies.-complaint history review: there have been no other reported events for the lot referenced.Conclusions: the investigation concluded that at no point were the femoral component and baseplate co-exisiting at the (b)(4) manufacturing facility.The femoral components were fully distributed from the finished goods warehouse in (b)(4) manufacturing facility by 06-aug-2015.Manufacturing of the baseplates in the (b)(4) manufacturing facility commenced on 08-sep-2015.It is possible that the mix-up may have occurred in (b)(6) and stryker (b)(4) has raised a non-conformance, to address this issue in their facility.No further investigation for this event is required at this time.
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Event Description
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It was reported that upon opening a box labeled triathlon cruciate retaining femoral [right cemented] , it was discovered that the inner content did not match the outer label.
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Search Alerts/Recalls
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