The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical evaluation indicated that it was reported that after trailing with a 52mm acetabular cup, the definite cup ¿would not seat¿ and the surgeon ¿had to use a bigger size cup¿.The root cause of the event could not be determined based on the limited information provided.Per correspondence, the surgeon was ¿happy with outcome¿ and did ¿not anticipate any further patient impact¿; therefore, patient impact beyond the reported minor surgical extension would not be anticipated, although this could not be definitively concluded.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to wrong size, surgical technique, alignment.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
|