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.Review of sterilization certification confirms device was sterilized in accordance with iso (b)(4).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and allergic reaction." 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 mdrs filed for the same event (reference 1825034-2015-05160 / 05161 / 05162 / 05163).
|
It was reported by the patient's legal counsel that patient underwent right total hip arthroplasty on (b)(6) 2011.Subsequently, patient underwent a tendon release procedure on (b)(6) 2014 due to chronic tendonitis.Patient was then revised on (b)(6) 2014 due to pain secondary to bursitis of the greater trochanter and chronic tendonitis.During the procedure the femoral head was removed and replaced with an active articulation liner and head.Patient then underwent another revision on (b)(6) 2014 due to infection.During the procedure the stem, cup, and head were removed and replaced with a spacer mold.On (b)(6) 2015 the spacer molds were removed and replaced with a stem, acetabular cup, and an active articulation liner and head.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.
|