It was reported that there was an issue with no165z-as univation xf tibia zementiert t4 lm.It was reported on (b)(6) 2018, that as a result of having the product implanted, the patient has experienced unknown claims and it is known that it resulted in a revision surgery.The primary surgery occurred on (b)(6) 2016, and the revision surgery occurred on, (b)(6) 2017.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: no188z (femur cemented f4 lm), nl473 (pe insert t4 rm/lm 7mm), nx044 (universal patella p4), np583r (threaded pin, headless 3.2mmx63mm).
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