Catalog Number UNK HIP FEMORAL STEM RECLAIM P |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 07/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # :(b)(4).D4: the devicevailable.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 was revised due to septic left hip.Shell, liner, screws, head & proximal body were removed.Off label one 40x68 +4/10 pinnacle line was cemented in w/antibiotics and off label a 28x105 reclaim proximal body was attached along w/a 12/14 articuleze 40x15.5 metal head.Doi: unknown.Dor: (b)(6) 2023.Affected side: left hip.
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Event Description
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Additional information received: a.Please clarify the affected side involved in the 68 pinnacle revision shell.Was there a bilateral revision surgery performed? left b.Please clarify what the off-label use was for the femoral head and proximal body.Re- implanting a reclaim proximal body onto an existing implanted reclaim distal stem.Also cementing a pinnacle liner.
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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.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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