It was reported patient underwent a right total hip arthroplasty on (b)(6) 2001 and a left total hip arthroplasty on (b)(6) 2002.Subsequently, patient underwent a left hip revision procedure on (b)(6) 2015 allegedly due to elevated metal ion levels, rashes and vertigo.It was further reported that the acetabular cup removal tool was unable to release the cup and the cup was removed with the screws still intact.It was reported that the patient's pelvic bone was allegedly fractured during the removal of the acetabular cup.The modular head, metal liner and acetabular cup were removed and replaced and a competitor cup removal tool was utilized to complete the procedure.A 60 minute delay was reported.There has been no reported right hip revision procedure to date.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 1 of 5 mdrs filed for the same event (reference 1825034-2015-02021 / 02025).
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