VERSA-DIAL/COMP TI STD TAPER
Received May 18, 2026
Report 0001825034-2026-01337 · MDR key 25203777
Device
Generic name
Prosthesis, Shoulder
Manufacturer
Zimmer Biomet, Inc.Catalog number
118001
Lot number
J7629976
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Loss of Range of Motion
- Muscle/Tendon Damage
- Aseptic loosening
Narrative
Additional Manufacturer Narrative
(B)(4). D10: ITEM#: 113057, VERSA-DIAL 50X27X50 HUM HEAD, LOT#: J7501632. ITEM#: 12-113558, COMPR 8MM HUM FRACT STEM PPS, LOT#: 66511856. G2: FOREIGN - EVENT OCCURRED IN MALAYSIA. 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.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER HEMIARTHROPLASTY DUE TO HUMERAL NECK FRACTURE. THE PATIENT IS REQUESTING PRODUCT IDENTIFICATION TO SCHEDULE REVISION DUE TO PAIN AND LIMITED RANGE OF MOTION. PATIENT STATES ADDITIONAL RADIOLOGY REPORTS PROVIDE FINDINGS OF A COMPLETE TEAR OF THE TENDON AND SUSPICION OF LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.