Product complaint #: (b)(4).This device was also subject of (b)(4) and (b)(4) as the patient experienced adverse events on different days with the same device.Initial reporter occupation: lawyer.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.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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Product complaint (b)(4).Additional information provided "the depuy patella was well-fixed and retained and osteophytes were removed from the patella." due to new information received, it is reasonable to conclude that retained patella did not provide any evidence of having caused/contributed to the reported harm(s),as the surgeon elected to not revise the retained implant(s).Depuy synthes joint reconstruction does not consider this failure to be a reportable event at this time.Further updates will only be provided if additional information is received that changes the regulatory determination.
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