REFOBACIN BONE CEMENT R 1X40-3
Received Feb 24, 2026 · Event occurred Dec 27, 2025
Report 3006946279-2026-00009 · MDR key 24428245
Device
Generic name
Bone Cement, Antibiotic
Manufacturer
Biomet France S.a.r.l.Catalog number
3003940001-3
Lot number
AX39BH3001
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Seroma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A SUBCUTANEOUS FLUID COLLECTION DEVELOPED IN THE LEFT GROIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). MDR-REPORT #: MW5182072. MDR-REPORT KEY: (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 ¿ UNKNOWN WHICH COUNTRY THE EVENT OCCURRED IN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540 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.