(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 will be filed as appropriate.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
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Complaint description: patient was revised to address discomfort.Update: in addition to what was previously reported, litigation also alleges the patient suffers from pain.Update: in addition to what were previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2007 - dor: (b)(6) 2014, (left hip).
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