Catalog Number UNK HIP ACETABULAR LINER CERAM |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Joint Laxity (4526)
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Event Date 09/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the patient came into see the surgeon with a dislocating unstable hip.Surgeon removed the 50 duralock liner and 50 duralock cup.He planned to cement in a 49 bimentum cup but was unsuccessful as the cup was loose.He determined that the bone graft behind the cup was preventing stability with the cement.He removed the cemented bimentum and instead put a g7 zimmer cup in.The lot numbers on the liner and cup were unreadable.It also appears that the stem was not zimmer as previously thought and was depuy.A 28 +1.5 ceramic head was removed.No numbers could be read as well.Doi: unknown.Dor: (b)(6) 2022.Affected side: unknown 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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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