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-502 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that upon opening the implant, a stain-like substance was present on the unit.
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Manufacturer Narrative
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An event regarding a stain on a femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: the femoral component was returned wrapped in a plastic bag inside its unit carton.No blister packs were returned with the device.There is evidence of staining on the internal fixation surface of the lateral condyle, around the threaded hole.The bearing surface of the femoral component appears unremarkable.-medical records received and evaluation: not performed as no medical records were provided.-device history review: indicated that the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the investigation concluded that the stain is a result of a water mark that remained after the cleaning process and affected a small percentage of triathlon ps parts.New holding baskets were introduced in the clean and passivate lines layton 1 & 2 without prior change control approval.The design of the new holding baskets along with the triathlon ps part geometry and insufficient drying on layton 1 contributed to the retention of water on the part which led to the eventual water marking of the parts over time.The staining was not obvious immediately and occured over time.The mark is currently a part of a visual standard inspection post passivation.An nc was issued on 24 - nov - 2016 for stain on femoral component triathlon ps parts and closed on 31 january 2017.A subsequent capa was raised on 08-dec-2016.All corrective actions have been implemented to prevent a recurrence of the non-conformance.A severity assessment was completed on the stain, resulting in a very low risk rating.Organic residual testing, endotoxin (lal) testing and cytotoxicity testing were all complete.No issues were reported.This product was deemed safe for intended use.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 the implant, a stain-like substance was present on the unit.
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Search Alerts/Recalls
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