STRYKER ORTHOPAEDICS-MAHWAH MRHK FEM DISTAL BLK 10MM XS; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6481-1-200 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 09/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not returned.
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Event Description
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Its reported by the attorney, through the filing of a legal claim, that the patient underwent knee surgery on (b)(6) 2016 due to a fractured left proximal tibial allograft, catastrophic failure, left alloprosthetic arthroplasty.It's further alleged that the patient underwent one stage left knee endoprosthetic revision, radical synovectomy on (b)(6) 2019 due to infection.
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Manufacturer Narrative
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Reported event: an event regarding infection involving mrhk fem distal blk 10mm xs was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records and x-rays were rejected by a clinical consultant stated the following comment: cannot confirm event, need additional information; revision operative reports, clinical and past medical history, additional serial dated x-rays, unlabeled photo showing dark material needs surgical pathology to confirm metallosis and pathology and examination of explanted components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.No other similar events for the sterile lot referenced.Conclusion: it was reported that the patient was revised due to infection and metallosis caused by defective stryker product.The reported event cannot be confirmed or the exact cause of the event cannot be determined as insufficient information was provided.Additional information including operative reports, progress notes, x-rays, pathology reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.H3 other text : device not returned.
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Event Description
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Its reported by the attorney, through the filing of a legal claim, that the patient underwent knee surgery on (b)(6) 2016 due to a fractured left proximal tibial allograft, catastrophic failure, left alloprosthetic arthroplasty.It's further alleged that the patient underwent one stage left knee endoprosthetic revision, radical synovectomy on (b)(6) 2019 due to infection.
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Search Alerts/Recalls
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