It was reported that the surgeon was placing the acetabular cup implant into the right hip.The cup being placed required the use of an impactor.Once the cup was placed, the surgeon unscrewed the cup impactor from the implant.Once the impactor was out, the surgeon examined the tip and discovered a thread on the impactor was stripped and there were metal shavings.The surgeon removed the visible metal shavings.The procedure was completed without any other issues.The patient was transferred to recovery in stable condition.X-ray of the right hip in recovery revealed a small piece of the metal shavings located at the tip of the trochanter.The surgeon did not try and recover the piece of the metal shaving because it would have caused more harm to the patient.
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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.Corrected:h6(device codes).Product complaint # (b)(4).Investigation summary : the instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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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