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.¿ product location unknown.
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It was reported that the clinical patient underwent a right partial knee procedure on (b)(6) 2008.Subsequently, patient underwent an arthroscopic procedure on (b)(6) 2013 due to pain.During the procedure, a synovectomy, lysis of adhesions, and removal of an osteophyte occurred.A band of scar tissue impinging upon the prosthesis was also noted.The patient was revised to a total knee system on (b)(6) 2013 due to unknown reasons.
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