Product complaint # (b)(4).D4: 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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This complaint is from a literature source.The following literature cite has been reviewedmarconi d, vigorita v, bryk e.Histological findings in six failed metal-on-metal implants.J long term eff med implants.2017;27(1):85-96.Doi: 10.1615/jlongtermeffmedimplants.2018020685.Pmid: 29604953.Objective and methods: adverse reaction to metal debris (armd) and alval are major causes of implant failure leading to revision surgery in patients with metal-on-metal (mom) hip arthroplasties.However, the pathogenesis and its association to implant wear are poorly understood and previous studies have yielded discrepant results.The purpose of this article was to retrospectively review six cases of patients who underwent mom hip arthroplasties and required early revision.Tissue removed at revision surgery was analyzed histologically by two independent reviewers.All six patients (four males, two females) underwent revision hip arthroplasty after early failure.Revision occurred between 18 and 56 months after the index procedure.Four patients received asr-xl mom implants from depuy, the other two were competitor constructs.This complaint will capture the 4 asr-xl revisions.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: asr xl (femoral, sleeve, cup, stem) adverse event(s) and provided interventions associated with depuy devices: case 1: 60-year-old female patient.Case 2: 60-year-old male patient.Case 3: 61-year-old female patient.Case 5: 56-year-old male patient.All patients were revised for the same reason and all patients had the same histological and device findings: evidence of metal wear and corrosion on all 4 devices.Pain, synovitis, metallosis, erosion of the tissues around the devices, soft tissue necrosis, scar formation, inflammation, and soft tissue injury to the surrounding tendons, ligaments, and musculature.
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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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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