TM REVERSE 2.5MM PIN STERILE
Received May 21, 2026 · Event occurred Apr 15, 2026
Report 0001822565-2026-01675 · MDR key 25246781
Device
Generic name
Prosthesis, Reverse Shoulder
Manufacturer
Zimmer Biomet, Inc.Catalog number
47430902501
Lot number
67353840
Product problems
- Fracture
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE BASEPLATE CENTERING PIN BROKE OFF DURING SURGERY. IT WAS NOT NOTICED DURING THE PROCEDURE, BUT DISCOVERED IN A FOLLOWUP X RAY THAT A FRAGMENT HAD FRACTURED AND BEEN RETAINED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4): D4: PRODUCT ID WAS PROVIDED FOR TWO PINS HOWEVER, IT IS UNKNOWN WHICH OF THE TWO PINS HAS BROKEN. THEREFORE, THE AFFECTED PIN COULD BE ANY OF THE FOLLOWING: 47430902501 - TM REVERSE 2.5MM PIN STERILE- 67353840 UDI: (B)(4) MANUFACTURING DATE: JUL 21, 2025 EXPIRATION DATE: JUL 15, 2035. 47430902501 - TM REVERSE 2.5MM PIN STERILE - 67574693 UDI: (B)(4) MANUFACTURING DATE: JAN 10, 2025 EXPIRATION DATE: SEP 26, 2035. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.