Batch review performed on 12 june 2018.Lot 174726: 73 items manufactured and released on 08 november 2017.Expiration date: 2022-10-19.No anomalies found related to the problem.To date, 5 items of the same lot have been already sold without any similar reported event.Reverse shoulder system humeral reverse hc liner ø36/+0mm reference (b)(4); lot 173417: 78 items manufactured and released on 27 june 2017.Expiration date: 2022-06-08; no anomalies found related to the problem.To date, 45 items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d product manager on (b)(4) 2018 the visual inspection confirms that the glenosphere reports scratches on the articular surface.No signs of breakage are visible on the outer border of the reverse liner.No root case can be identified on the investigated implants clinical evaluation performed by medical affairs director on (b)(4) 2018 recurrent dislocation of reverse shoulder arthroplasty 3 months after primary implantation.This event may be due to soft tissue deficiency , resulting in failure to provide sufficient stability.The insert was exchanged to a thicker one to recreate soft tissue tension.The implanted components did not mobilize, nor did they fail in any way.No information on the origin of scratches on the glenosphere is available.
|