Catalog Number UNK HIP ACETABULAR LINER CERAM |
Device Problems
Fracture (1260); Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/30/2022 |
Event Type
Injury
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Event Description
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Revision hip for smashed pinnacle ceramic liner.Removal of ceramic debris and replaced with a polyethylene liner.Femoral component believed to be an exeter (stryker) component.I was not present at the case and am not aware of the side left or right.The primary surgeon is unknown however was believed to be at north shore sydney.I could make an educated guess as to who the primary surgeon.Unknown what impact caused the liner to shatter.I was not at the case and have limited knowledge.Doi: unknown.Dor: (b)(6) 2022.Unknown hip.
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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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Additional information received indicates that a competitor cup was involved.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D10 (updated the unk hip acetabular cup pinnacle to competitor cup.).
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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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