Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problem
No Code Available (3191)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Customer would like to establish whether the company manufactured the aml hip stem femoral heads and also liner implants for this cup.No details are available on what acetabular cup this is or when the stem was originally implanted.No product codes are available either.The acetabular liner is reported due to revision to address wear.There is no alleged patient harm resulting from the alleged implant noise, therefore, the femoral head is not reported as this time.The attached document from the surgeon indicated the squeaking is due to the metal-on-metal bearing caused by the degree of acetabular wear.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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