It was reported that there was an issue with as columbus knee.It was reported that as a result of having the product implanted, the patient has experienced knee pain, swelling, difficulty walking and loosening of the device.The primary procedure occurred on an unspecified date, and the revision was performed on (b)(6) 2017.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nr003z (ps femur cemented f3l).Nr400z (femur stem nut all sizes neutral).Nr291z (femoral stem cemented 6° neut d12x77mm).Nr072z (ps tibia cemented t1+).Nr191z (tibial offset stem cemented d12x52mm).Nr614m (ps hc pe insert t1/t1+ 18mm).The cement used is unidentified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00465, 2916714-2020-00466, 2916714-2020-00467, 2916714-2020-00468, 2916714-2020-00469.
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