ONE-THIRD TUBULAR PLT 4 HOLE
Received Mar 25, 2026 · Event occurred Dec 4, 2023
Report 0001822565-2026-00954 · MDR key 24688952
Device
Generic name
Fixation, Nail/blade/plate Combination, Single Component
Manufacturer
Zimmer Biomet, Inc.Catalog number
47493500403
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Female
- Pain
- Loss of Range of Motion
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. 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 THE PATIENT UNDERWENT PLATE REMOVAL APPROXIMATELY 1 YEAR POST-IMPLANTATION DUE TO PAIN AND REDUCED RANGE OF MOTION. THE EVENT WAS IDENTIFIED THROUGH A STUDY DATABASE REVIEW. FOLLOWING REMOVAL OF THE METALWORK, A JOINT INJECTION WAS ADMINISTERED. THE PATIENT EXPERIENCED RESOLUTION OF SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.