Catalog Number 121732058 |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526)
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Event Date 03/28/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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It was reported that the patient had multiple dislocations post total hip replacement.She was scheduled for conversion from a standard bearing to a dual mobility bearing to increase stability.Patient mentions to surgeon during preop that she is experiencing some groin pain also.Intraoperatively the hip is found to be relatively stable.However when the cup is checked, there appears to be some movement and is removed showing fibrous ingrowth only.The acetabulum is prepared and a new cup is placed along with a screw for adjunct fixation.A dual mobility bearing is placed and a slightly longer construct is chosen as it created a more stabile construct for the patient.There was no delay or harm to the patient.Doi: (b)(6) 2022; dor: (b)(6) 2024; affected side: right hip.
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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.
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Search Alerts/Recalls
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