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, swellling, difficulty walking, and loosening and instability of the device.The primary procedure occurred on (b)(6) 2014, and the revision was performed on (b)(6) 2018.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nx011z (ps femur cemented f5n lt).Nx053z (ps tibia cemented t2).Nx043 (universal patella p3).Nn261z (tibial obturator d12mm, l7mm).The cement used was unspecified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00472.2916714-2020-00473.2916714-2020-00474.
|