Pcf and medical records received.After review of medical records patient was revised to addressed failed left total hip arthroplasty, adverse tissue reaction to metal debris.Operative notes indicated a very large effusion in the joint and pain.Scar tissue around the posterior capsule was noted.A large flush of volume fluid certainly much larger effusion than a typical hip, a yellowish, slightly cloudy fluid.Upon opening the capsule there was a little bit of synovitis on the inside of the capsule.Cup and stem was well fixed and well positioned.Doi: (b)(6) 2004; dor: (b)(6) 2018; left hip.
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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.H10 additional narrative: product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for 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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