Asr medical records received.After review of medical records, the patient was revised to address pain and metal wear of asr implants.The hip was aspirated and clear fluid was sent for cell count which was negative for acute inflammation.Tissues were sent for testing and again, was negative for acute inflammation.The tissues were noted to have the appearance of a foreign body reaction consistent with metal debris.There was some black staining of the trunnion consistent with metal corrosion.There was little to no bony ingrowth on the cup.Doi: (b)(6) 2008; dor: (b)(6) 2017; (left hip).
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected: h6 (closure codes and device codes).Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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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