Catalog Number 121887354 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Tissue Injury (4559)
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Event Date 03/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).E3 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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Event Description
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Medical records received on 14 july 2023; pc was created to capture the event.On (b)(6) 2023 patient was revised due to failed total hip arthroplasty, conversion of previous to a complex total hip arthroplasty posterior approach.Operative notes indicated that the gluteus minimus was atrophic and thin and affected by the metallosis.The dense tissue particularly in the inferior aspect was marked with black and metallosis which was noted as it was excised.We noted the central portion of the acetabulum had a thick fibrous tissue where there was defect superior dome had good native bone.The posterior wall had osteolytic loss as did the anterior rim.This was explanted and replaced with a competitor devices.Doi: (b)(6) 2006 (cup, liner, screw); dor: (b)(6) 2023; left 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.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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