STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL AUGMENT; 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
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 12/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.The rep believes he may be able to return the explants, and will try to obtain further information.
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Manufacturer Narrative
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Additional information: update to explant date.An event regarding loosening involving an unknown femoral augment was reported.The event was not confirmed.Method & results: -device evaluation and results: the augment was returned for evaluation still attached to the femoral component.There is nothing remarkable to note.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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, primary and revision operative reports, clinical and past medical history and additional serial dated x-rays 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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Event Description
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It was reported that the patient's right knee was revised.Pre-op diagnosis was for suspected loosening of the tibial baseplate.A pre-op x-ray also revealed that the bottom nub of the baseplate had become unthreaded from the baseplate.Intra- operatively, loosening of the femoral component was also noted.The patient's knee construct was revised to a ts knee with stems, cones, and augments.There are no allegations against the revised insert.The rep believes he may be able to return the explants, and will try to obtain further information.
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Search Alerts/Recalls
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