MSS - Humeral reverse liners

Description of Event or Problem

At about 2 weeks after the primary, the patient came in presenting pain due to a dislocation of the glenosphere and liner and the cause is unknown. The surgeon revised the liner, metaphysis, and glenosphere. The surgery was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 21 July 2026 Reverse Shoulder System 04.01.0478 Humeral reverse E-CROSS liner D 36/+0mm (K250338) Lot. 2502173: (b)(4) items manufactured and released on 04-Apr-2025. Expiration date: 2030-03-24. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review. Reverse Shoulder System 04.01.0110 Humeral reverse metaphysis +0mm/0° (K170452) Lot. 2601365: (b)(4) items manufactured and released on 18-March-2026. Expiration date: 2031-03-05. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review. Root cause: Dislocation is possible literature described adverse event after primary joint arthroplasties and causes are often unknown. There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.