Model Number 1570-01-120 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Musculoskeletal problem (4535)
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Event Date 01/21/2021 |
Event Type
Injury
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Event Description
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70-year-old female patient received a left hip revision to treat impingement secondary to dislocation and liner disassociation.Upon entering the joint, the surgeon identified and debrided metallosis caused by metal debris.The liner was disassociated due to locking mechanism failure, causing the summit femoral stem to impinge on the failed locking ring generating wear on the trunnion and metal debris.The cup and stem were well-fixed and retained.The patient a bimentum dual mobility articulating surface to replace the revised head and liner.The procedure was completed without complications.Head, liner and stem were revised.Doi: (b)(6) 2008(cup, stem).Doi: (b)(6) 2017(head, liner).Dor: (b)(6) 2021.Left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).This device was also subject of (b)(4) as the patient experienced adverse events on different days with the same device.Initial reporter occupation: lawyer.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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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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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