FDA Adverse Event
Injury
Summary report: N
REFOBACIN BONE CEMENT R 1X40-3
MDR report key: 24428245
·
Received February 24, 2026
Report
- Report Number
- 3006946279-2026-00009
- Event Type
- Injury
- Date Received
- February 24, 2026
- Date of Event
- December 27, 2025
- Report Date
- February 24, 2026
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- MBB
- UDI-DI
- 70887868358387
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(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.
Description of Event or Problem · 0
IT WAS REPORTED THAT A SUBCUTANEOUS FLUID COLLECTION DEVELOPED IN THE LEFT GROIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489123 | REFOBACIN BONE CEMENT R 1X40-3 | BONE CEMENT, ANTIBIOTIC | MBB | BIOMET FRANCE S.A.R.L. | AX39BH3001 | 70887868358387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |