BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 60 REFOB BONE CMT R-3

    MDR report key: 25137049 · Received May 11, 2026

    Report

    Report Number
    3006946279-2026-00020
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    04040029922361
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: FIXED TIBIAL INSERT; REF 02.12.0410FR; LOT 2005227 (MANUFACTURER: MEDACTA INTERNATIONAL SA) PATELLAR RESURFACING; REF 02.07.0036RP; LOT 2011091 (MANUFACTURER: MEDACTA INTERNATIONAL SA) FIXED TIBIAL BASEPLATE; REF 02.07.1204R; LOT 2004706 (MANUFACTURER: MEDACTA INTERNATIONAL SA) FEMORAL COMPONENT; REF 02.12.1005R; LOT 1810137 (MANUFACTURER: MEDACTA INTERNATIONAL SA). G2 - FOREIGN: SWITZERLAND G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172408. 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 APPROXIMATELY FIVE YEARS AFTER INITIAL IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING AND SUBSIDENCE OF BOTH THE TIBIAL AND FEMORAL KNEE COMPONENTS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471287 OPTIPAC 60 REFOB BONE CMT R-3 BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AZ15BB2411 04040029922361

    Patients

    Seq Age Sex Outcome Treatment
    1