BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 80 REFOB PLUS BONE CMT-3

    MDR report key: 24615858 · Received March 17, 2026

    Report

    Report Number
    3006946279-2026-00013
    Event Type
    Injury
    Date Received
    March 17, 2026
    Report Date
    March 17, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    04040029922392
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 00880304990197. D10: ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS) RIGHT 12 MM HEIGHT, 42522600712, 65546350. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E, 42532007102, LOT 65561390. STEM EXTENSION TAPERED CEMENTED 14MM DIAMETER +30MM LENGTH, 42557000114, LOT 65845249 . FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 7, 42500606202, LOT 65625058. G2: FOREIGN - EVENT OCCURRED IN SOUTH AFRICA. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN COMPLICATIONS. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677440 OPTIPAC 80 REFOB PLUS BONE CMT-3 BONE CEMENT MBB BIOMET FRANCE S.A.R.L. AX15BD1106 04040029922392

    Patients

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