It was reported that the patient was experiencing dislocations in right hip possibly due in part because of weight loss combined with aging.The surgeon initially planned to increase the neck length of the head ball, but due to her soft tissue laxity and with the acetabular cup being in a somewhat vertical position, decided to replace the acetabular component.Implant remaining in patient: 1554-01-121 dw2a51000 aml small stature stem 12.0mm doi: (b)(6) 2009.Dor: (b)(6) 2019.Right 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.Additional narrative: corrected: adverse event problem (device code).Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.Device history lot: null.Device history batch: null.Device history review: null.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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