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.¿ device remains implanted.
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It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2012.The patient reported experiencing a pop, swelling, and pain after physical exertion.However, no revision has been reported at this time.No further information has been provided.
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