The devices, intended for use in treatment, were not returned for evaluation and the reported event could not be confirmed.A clinical evaluation was conducted and confirms it cannot be determined to what extent the patient¿s fall, muscle atrophy and tissue loss had on his pain and clinical status.Although the surgeon¿s indication that the significant muscle atrophy and capsule tissue loss may have been contributing factors to the multiple dislocations, the root cause of the reported hip dislocations cannot be confirmed and it cannot be concluded that the dislocations were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.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.Some potential probable causes of this event could include traumatic injury or muscle atrophy.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.
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