InjuryHSD
HUMELOCK II
Received May 21, 2026 · Event occurred May 7, 2026
Report 3009532798-2026-00022 · MDR key 25242124
Device
Generic name
Anatomic Shoulder Prosthesis
Manufacturer
Fx Shoulder SolutionsCatalog number
106-4316
Lot number
U0598
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Medical device site infection
Narrative
Description of Event or Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A HEAD AND A DOUBLE TAPER WERE EXPLANTED. A HEAD AND A DOUBLE TAPER WERE IMPLANTED.
Additional Manufacturer Narrative
THE EVENT TOOK PLACE OUTSIDE THE UNITED STATES (IN FRANCE) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET IN THE UNITED STATES.