STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_CORK_PRODUCT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_SHC |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 03/06/2024 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding loosening involving an unknown accolade 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.H3 other text : device not returned.
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Event Description
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It was reported that the patient's right hip was revised due to stem loosening.The stem, head and liner were revised.Rep confirmed that there were no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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