It was reported that there was an issue with as vega knee, left side.It was reported that as a result of having the product implanted, the patient has experienced knee pain and swelling; and normal daily activities were restricted due to the pain.The primary procedure occurred on (b)(6) 2013, and the revision was performed on (b)(6) 2016.Intraoperative findings showed loosening of the femoral component, metallosis and debris in the knee joint, and reactive synovitis.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx009z (ps femur cemented f4n lt).Nx042 (universal patella p2).Nx049z (ps tibia cemented t0).Nx100 (ps pe insert t0/t0+, 10mm).Nn260p (peek plug f/ tibia).The cement used was unspecified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00506, 2916714-2020-00508, 2916714-2020-00509, 2916714-2020-00510.
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