Asr revision, asr resurfacing, right hip.Reason for revision: unknown / na.Patient died on (b)(6) 2013 due to unbearable pain in her hip.Doi: unknown.Dor: (b)(6) 2010, (right hip).
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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.Product complaint #: (b)(4).Investigation summary: no explanted devices have been received in respect of this patient for analysis.Manufacturing records have not been reviewed due to no lot numbers being provided.If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation.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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