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 per complaint details, the data presented in the literature review article refers to a patient that required a revision tha due to a subluxation within 45 days of the primary tha.Responses to the requested clinical documentation had not been received as of the date of this investigation; therefore, the root cause and the patient impact beyond that which is documented in the article could not be confirmed.No further medical assessment is warranted at this time.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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.
|