Shoulder System

Description of Event or Problem

At about 4 months after the initial surgery for a humeral fracture fixation, the patient underwent a planned revision procedure for implantation of a custom glenoid. During the surgery, the surgeon found the diaphysis to be loose. The stem was therefore revised and replaced with new implants. The procedure was completed successfully.

Additional Manufacturer Narrative

Batch review performed on 21 July 2026 Anatomical Shoulder System 04.01.0229 Long humeral diaphysis - L200 - 11 (K192967) Lot. 2216607: 29 items manufactured and released on 12-Dec-2022. Expiration date: 2027-11-22. No anomalies found related to the problem. To date, 18 items of the same lot have been sold with no similar reported events during the period of review. Root cause:Aseptic loosening is a possible literature-described adverse event following shoulder arthroplasties and causes are often unknown. In this case, the loosening likely resulted from poor bone quality and complex anatomical conditions following previous trauma, which limited the potential for osseointegration and mechanical stability. There is no indication that any potential issue with the device may have caused or contributed to the event.