Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2002.Subsequently, legal counsel reports that patient¿s right hip was revised on (b)(6) 2010 due to patient allegations of pain and loss of range of motion.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a right hip revision on (b)(6) 2010 due to pain and a fluid collection.Operative report noted the presence of cloudy fluid with white particulate matter, a cyst behind the cup, and lack of bony ingrowth on the cup.The modular head, liner and acetabular cup were removed and replaced with a competitor¿s cup and a biomet head.
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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 these types of events can occur under possible adverse effects: postoperative bone fracture and pain.This report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2014-05789, -07097, & -07684).
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