It was reported that there was an issue with as vega knee.It was reported that as a result of having the product implanted, the patient has experienced knee pain, swelling, difficulty walking, and loosening and instability of the device.The primary procedure occurred on (b)(6) 2016, and there was no revision performed.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).Nx210 (ps pe insert t1/t1+, 10mm).Nx052z (ps tibia cemented t1+).Nn261z (tibial obturator d12mm, l7mm).Nx043 (universal patella p3).The cement used is biomet cobalt hv bone cement (402282).The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00417, 2916714-2020-00418, 2916714-2020-00419, 2916714-2020-00421.
|