Batch review performed on 27-dec-2022: lot 2006175: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review additional device involved: batch review performed on 27-dec-2022: liner: cc e cc light 01.26.3648hct flat pe hc liner ø 36 / f (k103352) lot 2009643: (b)(4) items manufactured and released on 20-nov-2020.Expiration date: 2025-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review clinical evaluation performed by medacta medical affairs manager: revision 1 year and 10 months after the primary tha due to insufficient osteointegration of the proximal stem in a 79 year old male patient.Additionally, an intra-operative scar tissue formed around the stem was removed. radiographic images provided show a stem in varus position and possibly undersized.This could be the cause of the revision surgery but of course other evetns related to the post-operative period could have influenced the outcome.The revision surgery was completed successfully revising stem and head.Investigation perfomed by medacta r&d hip project manager: looking at the images attached to the complaint it is visible the stem covered with patient blood.On the body surfaces some residuals of ha coating are visible on the distal part of the stem and on the proximal part close to the resection line, meaning that the stem was not correctly osteointegrated with patient bone.On the neck part some signs and scratches are present probably due to revision surgery.It is not possible to determine the root cause of reported complaint.
|