STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON KNEE SYSTEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 03/27/2020 |
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.Device not returned.
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Event Description
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It¿s reported by the attorney, through the filing of a legal claim, that the patient underwent a right total knee arthroplasty on an unknown date in which he was implanted with a stryker triathlon knee system.It is further alleged that the patients right knee had to be revised on an unknown date due to mechanical loosening.
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Event Description
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It¿s reported by the attorney, through the filing of a legal claim, that the patient underwent a right total knee arthroplasty on an unknown date in which he was implanted with a stryker triathlon knee system.It is further alleged that the patients right knee had to be revised on an unknown date due to mechanical loosening.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving an unknown triathlon knee 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 by a clinical consultant indicated: no imaging studies are available for review and no examination of the explanted components is noted.There was no clinical improvement post-revision to competitive products, and no intraoperative or imaging studies diagnosis of either loosening or "failed" primary total knee components are noted.There is no evidence the persistent, chronic, compensable pain in the right knee is related to the primary total knee arthroplasty components, and apparently has persisted even after revision to completive products.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, x-rays 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.
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Search Alerts/Recalls
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