Pfs and medical records received.Pfs alleges significant pain, loose cup and infection.After review of medical records, the patient was revised for failed left total hip arthroplasty and right knee arthritis.Operative finding identified grossly loose cup and frozen section revealed multiple areas consistent with periprosthetic joint infection.Patient was implanted with prostalacs and non-depuy components.The patient underwent an open reduction internal fixation on (b)(6) 2018 to repair her fractured femur due to fall.Doi: (b)(6) 2011 (stem); doi: (b)(6) 2017 (cup, liner, head, screws); dor: (b)(6) 2018; 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.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 will be filed as appropriate.
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