After review of medical records the patient was revised due to mom aseptic lymphocytic dominated vasculitis associated lesion, alval, reaction with metallosis, loss of abductor and capsular soft tissue tension with dislocation due to impingement.Previous revision noted acetabular shell had poor position about 45-50 degrees anteverted.Unable to revised due to no explant device available during trialing.Operative note reported loss of muscle tissue and tendinous insertions.Confirmed poor position of the cup caused impingement.There was some minimal blood loss and bone loss noted.The patient had severe abductor restrictions due to paucity of the soft tissue restraints.Doi: (b)(6) 2017; dor: (b)(6) 2017 left hip.
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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.H10 additional narrative: product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.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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