GLENOID IMPACTOR
Received Jul 1, 2026 · Event occurred Jun 3, 2026
Report 0001822565-2026-02406 · MDR key 25680260
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
SBGL5001
Lot number
64859906
Product problems
- Crack
- Fracture
Patient
52 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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.
Description of Event or Problem
IT WAS REPORTED THAT UPON ROUTINE INSPECTION AFTER THE INSTRUMENTS CAME THROUGH THE WASHER IT WAS NOTED THAT THE GLENOID IMPACTOR ALSO CRACKS AND NEEDED REPLACEMENTS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.