EXPLOR 12X20MM IMPLANT HEAD
Received Mar 30, 2026 · Event occurred Jun 24, 2019
Report 0001825034-2026-00749 · MDR key 24716380
Device
Generic name
Elbow Radius Prosthesis
Manufacturer
Zimmer Biomet, Inc.Catalog number
11-210023
Lot number
424780
Product problems
- Inadequacy of Device Shape and/or Size
Patient
NA · Male
- Extraskeletal ossification
- Pain
- Loss of Range of Motion
- Scar Tissue
- Joint Contracture
- Aseptic loosening
Narrative
Additional Manufacturer Narrative
(B)(4). D10: ITEM #: 11-210063, EXPLOR 8X28MM IMPL STEM W/SCR, LOT # 811940. G2: FOREIGN - EVENT OCCURRED IN NORWAY. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - HEAD. 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 AFTER 21 DAYS POST IMPLANTATION PATIENT PRESENTED WITH CONTRACTURE ASSOCIATED WITH LOSS OF ROTATION, FLEXION, AND EXTENSION (0°, 100°, 20°). X-RAYS SHOWED EVIDENCE OF ECTOPIC BONE FORMATION. INTRAOPERATIVELY, SIGNS OF JOINT ¿STUFFING¿ AND A HEAD SIZE CONSIDERED TOO LARGE WERE OBSERVED. AN OPEN ARTHROLYSIS WAS PERFORMED, INCLUDING REMOVAL OF SCAR TISSUE AND ECTOPIC BONE FORMATION. SCARRING AGAINST THE TROCHLEA FROM THE PROSTHESIS HEAD WAS ALSO IDENTIFIED. THE PROSTHETIC HEAD WAS REMOVED AND REPLACED WITH A SMALLER HEAD MEASURING 20 MM WITH A 10 MM LENGTH. POST-OPERATIVE RADIATION THERAPY WAS PLANNED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.