BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CEMENT R 10X2 GERMAN

    MDR report key: 23072371 · Received September 17, 2025

    Report

    Report Number
    3006946279-2025-00108
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    July 3, 2025
    Report Date
    January 8, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOLOGICAL EXAMINATION REVEALS LOOSENING OF THE DAMAGED TIBIAL COMPONENT DUE TO BLOCKAGE OF THE WORN MOBILE POLYETHYLENE BETWEEN THE NOTCH AND THE EXTERNAL JOINT SPACE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D6A - PRODUCT IMPLANTED IN 2014 OUTSIDE HUG. D10 ¿ (B)(6), OXFORD DOMED LAT MEN BRNG MD SZ 4, LOT 3203664. (B)(6), AGC DA 2000 FEMORAL LEFT 60MM, LOT 3194474. (B)(6), REFOBACIN BONE CEMENT R 10X2 GERMAN, LOT A335AC1403. (B)(6), OXF DOMED LAT TIB TRAY SZ C-UK, LOT 3349283. G2 ¿ FOREIGN ¿ SWITZERLAND. G-4: 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE PARTIAL LEFT KNEE PROSTHESIS ELEVEN YEARS POST IMPLANTATION. DUE TO A FALSE MOVEMENT TWO MONTHS PRIOR REVISION, THE SUB-LUXATION OF THE POLYETHYLENE OCCURRED, AND THE PATIENT HAS BEEN IN PAIN, WITH PERSISTENT EXTENSION DEFICIT. RADIOLOGICAL EXAMINATION REVEALED LOOSENING OF THE DAMAGED TIBIAL COMPONENT DUE TO BLOCKAGE OF THE WORN MOBILE POLYETHYLENE BETWEEN THE NOTCH AND THE EXTERNAL JOINT SPACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598224 REFOBACIN BONE CEMENT R 10X2 GERMAN BONE CEMENT MBB BIOMET FRANCE S.A.R.L. C308AC1403

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| H SEE H11 NARRATIVE.