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 1 states, "material sensitivity reactions." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 13 states, "problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies." 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 patient¿s complaint and the allegations contained therein are unverified.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2015-03860 / 03861 / 01445).
|
Legal counsel for the patient alleges that patient underwent a left total hip arthroplasty on (b)(6) 2006.Patient's legal counsel reports patient allegations of pain, swelling, inflammation, lack of mobility, loss of range motion, dysfunction, elevated metal ion levels and damage to surrounding bone and tissue.No revision has been reported.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Additional information received in operative report noted patient underwent a revision procedure on (b)(6) 2014 due to elevated metal ions, pain, and leg length discrepancy.Operative report further noted significant scarring, "significant trunnion changes", loose cup, delamination of the porous coating from the cup superolaterally, and significant abductor damage during the revision procedure.The head and cup were explanted and replaced with a legacy zimmer cup and liner with an unknown head.
|