It was reported that the surgeon took out 56mm pinnacle cup with two screws, no information available on screws.Metal liner, no information available on the liner, 40mm +5 head, 5 high trilock stem.The cup was vertical, metal debris was present in the hip joint.It was also indicated that there was loosening of the cup an stem at the bone to implant interface.The cup, screws and liner were all still intact.No way to get further information off these implants.Doi: unknown; dor: (b)(6) 2019.
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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).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.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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