(b)(4).The reported event was identified during review of a journal article.M.H.Hjorth, et al.Does a titanium sleeve reduce the frequency of pseudo tumors in metal-on-metal total hip arthroplasty at 5-7 years follow-up? the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 01779.
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