The primary surgery was performed on (b)(6) 2019 via tha.It was reported that there was no problem at postoperative x-ray just after the primary surgery, however it was detected that a fracture line from greater trochanter to lesser trochanter.Thus, the revision surgery was performed on (b)(6) 2019 by replacing the head (p/n: 136532310), the stem (p/n: l971110) to c-stem amt.The cup was retained.The surgery was completed without a surgical delay.
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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.Additional narrative: product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.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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