STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIATHLON 12 X 100 TS STEM; 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); Inadequate Osseointegration (2646)
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Event Date 01/19/2024 |
Event Type
Injury
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Event Description
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As reported: "right mrh revision.Pt.Presented with complaints of femoral pain.Imaging determined the mrh femoral construct was loose, requiring revision.Original dos is unknown.Revised the femur to the components listed in the attached surgery sheet.Tibial components were left in-situ, no complaints filed against the components themselves." rep confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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An event regarding loosening involving an unknown triathlon 12 x 100 ts stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: no medical records were received for review with a clinical consultant.-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, operative reports, progress notes, 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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