Legal counsel for patient reported that patient underwent initial right total hip arthroplasty on (b)(6) 2008.Subsequently, operative report noted patient was revised on (b)(6) 2013 due to loss of range of motion and pain.Operative report further noted a rotated acetabular cup during the procedure.The modular head, acetabular cup and femoral stem were removed and replaced with competitor product.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.
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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 4 states, "loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02319 / 02320).
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