It was reported that the patient underwent a right hip debridement due to an infection.No implants were removed in the procedure.All of the implants were used in treatment.As of today, additional information has been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.In (b)(6) 2013 (5 years post implantation) the patient presented with a late ¿acute hematogenous infection¿ of his right hip.He was treated with an open incision and drainage.The source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with implant failure.Without further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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