It was reported that, after a thr surgery had been performed on (b)(6) 1994, the patient experienced pain and migration of the implant.This adverse event led to a revision surgery performed on (b)(6) 2021 in which an unkn mts hip impl was explanted.The current health status of patient is unknown.
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, smith and nephew has not received the device and/or adequate clinically relevant documentation to fully evaluate the complaint.The impact to the patient beyond that which has already reported cannot be determined.Should any additional clinically relevant information be provided, this complaint would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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