Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.Corrective action was not indicated.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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It was reported that once the 1st revision surgery was completed (it¿s reported as (b)(4)).It was reported that the patient visited to the hospital in emergency on (b)(6) 2020 and it was confirmed that dissociation of the stem from the head.Thus, the 2nd revision surgery was performed on (b)(6) 2020 by replacing the head (p/n: 962713000), the liner (p/n: unknown) and it was confirmed that metallosis had occurred.The surgery was completed, and it was unknown whether there was a surgical delay or not.No further information is available.
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