Catalog Number 122136052 |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problem
Joint Laxity (4526)
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Event Date 04/08/2024 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2024 tabs on the poly liner failed, and it spun out.There was wear on both the poly and the ceramic head, possibly from impingement.Both of the implants were back to depuy.Doi: on (b)(6) 2021 , dor: on (b)(6) 2024, affected side: right hip.
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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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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: an analysis of the product could not be performed, since a physical sample was not received for 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.However, if the product is received at a later date, the investigation will be updated as applicable.Device history lot: a search of the depuy nonconformance (nc) quality system found, no nc¿s associated with this product/lot combination.
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Search Alerts/Recalls
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