Catalog Number UNK HIP ACETABULAR CUP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Stenosis (2263); Joint Laxity (4526)
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Event Date 07/15/2022 |
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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Patient had total hip replacement c-stem and pinnacle implants on (b)(6) 2022.Well positioned implants, very stable construct.Patient unfortunately had a heart attack on (b)(6) 2022 and subsequently dislocated his hip as he fell.This has resulted in hip instability ever since, surgeon has been trying to help manage this non-operatively until he was fit enough for a procedure.On this day, (b)(6) 2022, his primary acetabular liner was revised for a pinnacle dual mobility liner and the head was replaced with dual mobility implants to improve stability.Doi: (b)(6) 2022, dor: (b)(6) 2022, unknown side.
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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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