It was reported that the patient was revised due to pain.The patient has retained legal representation.Patient's original surgery was sometime in 2006.The patient appears to have a summit/ultamet metal metal tha.54mm cup with metal liner, 36mm +1.5 metal head ball.The acetabular cup, liner, and head ball were removed and revised.The surgeon implanted a gription 56mm cup, 40mm +4 liner and 40mm 8.5 ts ceramic head.The patient retained all implants removed by her legal team.Pictures of the implants removed are available.Doi: 2006.Dor: (b)(6) 2019.Unknown 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 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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