ALLIANCE GLENOID MODULAR AUGMENT CEMENTED GLENOID
Received Jul 21, 2026 · Event occurred Jun 26, 2026
Report 0001822565-2026-02657 · MDR key 25896661
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
SAGL2244
Lot number
66740918
Product problems
- Device Dislodged or Dislocated
Patient
NA · Unknown
- Joint Dislocation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION REVERSE SHOULDER ARTHROPLASTY DUE TO DISLOCATION. DURING THE REVISION, THE PREVIOUSLY IMPLANTED GLENOID AUGMENT AND CENTRAL POST WERE REMOVED AND REPLACED WITH A LARGER GLENOID AUGMENT AND NEW POST. THE HUMERAL HEAD AND TAPER ADAPTER WERE EXCHANGED FOR NEW COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4) G2: FOREIGN - THE EVENT OCCURRED IN UNITED KINGDOM. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 113032(J7810079). ASSOCIATED PRODUCT INFORMATION: SAGP0001(67053739) 118001(J7691127). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.