Section h10: (h3) the clinical evaluation noted the device was used for treatment, not diagnosis.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event, instability/subluxation, is related to the underlying patient condition of ruptured posterior cruciate ligament (pcl).(d11) concomitant devices: - tibial inserts cr cn; 02-012-47-3509 / sn; (b)(6) - fit tibial tray (cn: 02-012-45-3525 / sn: (b)(6).- three peg patella, 32mm cn: 200-02-32 / sn: (b)(6).No information provided in the following section(s): a2, a3, a4, a5, b6, and b7.The following section(s) have additional info: b5, g4, g7, h1, h2, h3, and h7.
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