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 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 20 states, "persistent pain.".
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It was reported that the clinical patient underwent an initial right partial knee arthroplasty on (b)(6) 2007.Subsequently, the patient was revised on (b)(6) 2008 due to pain, discomfort, loosening, and tibial overload.
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