This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: pinnacle gripton ac (shell), pinnacle dm metal liner, actis femoral stem, biolex ceramic femur, bimentum liner (b)(6) 2022.Model #: udi: the part number is unknown.All attempts to obtain product information were unsuccessful.Therefore, udi is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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It was reported that approximately three weeks following a surgical procedure of the hip the patient developed a superficial wound that required reoperation after using an unknown adaptor device for femoral broaching.It was reported that the initial procedure lasted 67 minutes.It was reported that there was no interoperative complications during the initial procedure.It was reported that irrigation and debridement was needed to treat the wound.It was reported that the patient is recovering, and the event is being resolved.It was reported that the procedure was part of a kincise clinical study.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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