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.(b)(4).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 14 states, "intraoperative or postoperative bone fracture of the femoral neck and/or postoperative pain." this report is based on allegations set forth in patients notice and the allegations there in are unverified.This report is number 2 of 4 mdrs filed for the same patient (reference 3002806535-2017-00090 / 00093).
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Legal counsel for patient reported hip revision approximately three years post-implantation due to pain, movement restriction, and cysts.Large muscle damage was noted.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
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