The literature article entitled, "acetabular medial wall displacement osteotomy in total hip arthroplasty" written by hong zhang, md, ye huang, md, yi-xin zhou, md, yi-xiong zhou, md, ming lv, md, and zeng-hui jiang, md accepted by publisher on 28 january 2005 was reviewed.The article's purpose was report on results of 26 patients who had acetabular dysplasia and were operated on by circumferential acetabular medial wall displacement osteotomy to reconstruct the acetabulum during total hip arthroplasty.Depuy and non depuy products were utilized.Operations were performed from march 2002 to december 2003 of 3 men and 23 women with age range of 19-70 years old.Results were no complications and no revision surgeries.Article notes radiographic readings of cup abduction angles ranging 30-53 degrees indicating mispositioned cups.Depuy products utilized: duraloc cups.Adverse event: cup mispositioning without revision.
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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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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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