This report was initially submitted under manufacturer number ¿3005975929¿, but smith & nephew received further information stating that the correct manufacturer number is ¿1020279¿ instead.The device, used in treatment, was not returned for evaluation as it remains in use.A clinical analysis indicated that although trunnionosis, pseudotumor and alval were noted intraoperatively, without the supporting lab results, imaging, and/or the analysis of the explanted components, the root cause of the trunnionosis, pseudotumor and alval cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the risk management file and instructions of use for the product was completed.Factors and/or some potential probable causes that could include but not limited to materials not adequate for indications and traumatic injury.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
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