STRYKER ORTHOPAEDICS-MAHWAH MRS FEM ROT HINGE RT 65MM BOD; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 2481-8-020 |
Device Problems
Corroded (1131); Metal Shedding Debris (1804)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 10/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with reported discrepancies.There has been no other events for the lot referenced.An event regarding tibial loosening involving an mrs femoral component was reported.The material analysis report confirmed corrosion.Method & results: -device evaluation and results: material analysis of returned device was performed and indicated that debris was observed on the femoral component of the implant.Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: an event regarding tibial loosening involving an mrs femoral component was reported.The material analysis report was confirmed to corrosion.Material analysis of returned device was performed and indicated that debris was observed on the femoral component of the implant.Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material.Further information such as pre- and post-op x-rays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be re-opened.
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Event Description
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Revision of mrs distal femoral replacement w/ all poly tibia for tibial loosening.Event update per review of the material analysis performed on (b)(6) 2017: "debris was observed on the femoral component of the implant.Eds showed the femoral component was consistent with astm f75 alloy and the debris was consistent with a corrosion process and biological material.No material or manufacturing defects were observed on the surfaces examined.".
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