Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Noise, Audible (3273)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 02/07/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Patient was revised due to liner disassociation.Implant date is unknown as it was done elsewhere.A 52 mm cup was found to be well fixed and the head was a 36mm +1.5 metal head.It is unknown if the head is an articuleeze or an m spec head.Patient presents in clinic with grinding and squeaking in the left hip.Xrays show what appears to be a pinnacle shell and a reclaim hip stem but the femoral head is not centered in the cup leading surgeon to believe that there was a liner disassociation.Patient was scheduled promptly and brought to the operating room for a hip revision.Hip is dislocated and femoral head removed.Liner is found to be disassociated from cup and significant metallosis is present.An extensive dibridement is performed and there is mild wear in the superior posterior redion of the cup.The inner taper of the cup appears to be unaffected and a dual mobility liner is placed uneventfully and impacted.The metal liner is well fixed and a dual mobility liner and head are placed.No patient harm was noted and no delay took place.Doi: unknown.Dor: (b)(6) 2024.Affected side: left.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.H10 additional narrative: added: b1 (is product problem).
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Search Alerts/Recalls
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