Medical records received.After review of medical records, the patient was revised to address painful left hip total hip replacement.Patient complains of left groin and buttock pain, scratching noise in hip, catching and numbness/tingling, difficulty sitting for prolonged periods of time, and joint swelling.Operative notes stated extensive intra-articular adverse tissue reaction with some changes of corrosion around the socket liner insert.Extensive scarring and soft tissue reaction were noted to the metal-on-metal hip.There was a surgical delay of 1.30 hrs due to difficulty dislodging the metal liner.Doi: (b)(6) 2010; dor: (b)(6) 2017 (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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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