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.¿.
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It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2012.Subsequently, patient experienced pain, crepitus, popping, swelling, and a lateral meniscus tear in the left knee.It was further reported that patient received injections to relieve left knee pain.No further information has been provided.
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