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 2 states, ¿early or late postoperative infection and/or allergic reaction.¿ number 6 states, "inadequate range of motion due to improper selection or positioning of components." this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.
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It was reported that patient underwent a left total hip arthroplasty on (b)(6) 2014.Subsequently, approximately two (2) months later patient experienced cipd (chronic inflammatory demyelinating polyneuropathy) and is being tested for suspected metal allergy.Patient alleges limited mobility, limited ability to walk or climb stairs and lack of mobility of his fingers.A revision procedure has not been reported at this time.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.
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