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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "material sensitivity reactions." number 11 states, "wear and/or deformation of articulating surfaces." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 4 mdr's filed for the same event (reference 1825034-2015-05156 / 05157 / 05158 / 05159).
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It was reported by the patient's legal counsel that patient underwent initial right total hip arthroplasty on (b)(6) 2007.Patient then underwent initial total left hip arthroplasty on (b)(6) 2008.Subsequently, patient underwent a left hip revision on (b)(6) 2014 due to alleged metallosis and elevated metal ion levels.During the procedure the acetabular cup and head were removed and a cup, head, and liner were implanted.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
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