Batch review performed on 30 september 2019: lot 120087: 60 items manufactured and released on 28-march-2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved: batch reviews performed on 30 september 2019: cup: versafitcup 01.26.52 mb acetabular shell cc ø 52 (k083116) lot 121034: (b)(4) items manufactured and released on 26-jun -2012.Expiration date: 2017-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 115762: (b)(4) items manufactured and released on 3-apr-2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
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The patient came in, three months after primary surgery, complaining of pain.The cause of the pain was an allergic reaction to nickel.Ths surgeon revised successfully head, cup and liner and implanted 36 mm biolox delta head s, mpact multi hole cup 56 mm and impact flat liner hc 36/f.
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