As of today, device return and additional information has been requested for this complaint but has not become available.Since no device part & lot details were received for investigation, no thorough manufacturing record review can be performed.The provided medical documents have been reviewed.This complaint is from the bhmh modular hip ous study reporting adverse event 1 for subject (b)(6) adverse event 1 is "armed involves operative site hip, moderate severity, treated with invasive or surgical procedure, right hip revision surgery performed with removal of the femoral head, acetabular cup and taper sleeve.No metal ion levels have been submitted.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.
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