Batch review performed on 25 may 2020: lot 082588: (b)(4) items manufactured and released on 13-oct-2008.Expiration date: 2013-09-30.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 since 1-1-2016.Other device involved in the event: stem: quadra-h 01.12.034 cementless, ha coated lat stem size 4 lot.082238 (k082792).Batch review performed on 25 may 2020: lot 082238: (b)(4) items manufactured and released on 14-0ct-2008.Expiration date: 2013-09-30.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 since 1-1-2016.
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Visual inspection performed by medacta r&d deprtment: visual inspection performed on 15-dec-2020.Except for the signs related to the extraction, no evident signs of loosening were found on the stem.From the received components, it is not possible to determine the root cause of the event,but we can exculde a failure of the device.Clinical evaluation performed by medacta medical affairs deprtment: 11 years after cementless primary tha both femoral and acetabular components are found loose and replaced.The stem appears in varus position but this was the situation also postoperatively in 2009.The cup is in a rarefied bone area, and again this was the case since primary surgery.However, bone quality and conditions have deteriorated over the years, probably creating the loosening conditions.We cannot identify other potential causes or anomalies from the images supplied.
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