It was reported from a literature study that the screw cut out the femoral head and the patient was changed to a hip prothesis.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A clinical analysis noted that one photo with four combined x-ray images labeled figure 7 in the article was provided for review and confirms the reported failure.No individual clinical information has been provided for inclusion in this medical investigation.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but not limited to user/procedural variance or surgical technique.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
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