H3, h6: the device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that during a revision surgery, while extracting the previously implanted femoral component, the stem impactor rod bent.The reason for the revision is unknown, and the requested x-rays and surgical records have not been provided.Per complaint details, a backup device was not applicable and there was no patient injury or surgical delay.The patient impact beyond the revision procedure cannot be determined.No further clinical assessment is warranted at this time.Should clinically relevant documentation be provided, this clinical/medical task may be re-evaluated.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.
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