It was reported that patient underwent right total knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2015 due to continuous pain, effusion, and increased stiffness.The surgeon felt that lack of bony ingrowth to the femoral component may have contributed to the issues reported.The femoral component and tibial bearing were removed and replaced.
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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: "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity.".
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