MalfunctionKWS
ALLIANCE®
Received Jul 8, 2026 · Event occurred Jun 12, 2026
Report 0001822565-2026-02488 · MDR key 25747223
Device
Generic name
Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
SBGL3007
Lot number
66809153
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). H6: PROPOSED ANNEX G CODING; MECHANICAL (G04) - DRILL. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET, AND THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A POST REAMER BECAME DAMAGED DURING REAMING OF THE GLENOID. THE DAMAGE OCCURRED WHILE REAMING EXCESSIVELY HARD GLENOID BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.