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 20 states, "persistent pain." remains implanted.
|
It was reported a clinical patient underwent an initial left partial knee arthroplasty on (b)(6) 2007.Subsequently, the patient experienced a pulmonary embolism on (b)(6) 2007.The patient reported pain on (b)(6) 2008, which was treated with cortisone injection.The patient reported experiencing pain and instability on (b)(6) 2016.
|