On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision (femoral stem) in cementless double mobility tha on a young lady after two years.The stem appears to be loose on the supplied radiographs.Some sclerotic lines are also visible around the cup, which has not been revised though.The stem appears to have a rather significant anteversion but this cannot be assumed to be the cause for loosening.Aseptic loosening is a possible adverse event following tha and very often, like in this case, the main cause remains unknown.Batch reviews performed on 21 august 2017.Lot 150841: (b)(4) items manufactured and released on 26 may 2015.Expiration date: 2020-04-30.No anomalies found related to the reported issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 28 size l +3.5, code 01.29.203, lot.148656 (k112115).(b)(4) items manufactured and released on 17 march 2015.Expiration date: 2020-02-29.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.Versafitcup double mobility hc liner ø 48/28, code 01.26.2848mhc, lot.151096 (k092265) (b)(4) items manufactured and released on 07 july 2015.Expiration date: 2020-05-31.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.
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