STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIATHLON 3X9 PS INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 04/03/2024 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding instability involving an unknown tibial insert 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.H3 other text : device not returned.
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Event Description
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It was reported that the patient's left knee was revised due to lateral laxity.A 3x9 ps insert was revised to a 3x9 ts insert.Rep confirmed that no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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