SHOULDER SYSTEM

Description of Event or Problem

REVISION SURGERY AFTER 3 MONTHS FROM THE PRIMARY DUE TO A LOOSE GLENOID CAUSED BY A SUSPECTED INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PATIENT TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 14 JULY 2026 04.01.0401 GRS BASEPLATE - D 24.5X20 - FULL WEDGE 15° (K231911) LOT. 2339034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 SEPTEMBER 2024. EXPIRATION DATE: 06 SEPTEMBER 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, THE EARLY LOOSENING OF THE GLENOID COMPONENT MAY HAVE BEEN ASSOCIATED WITH THE SUSPECTED INFECTION. AS THE INFECTION WAS NOT CONFIRMED, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, AND THERE IS NO INDICATION OF A DEVICE-RELATED CAUSE.