BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 40 REFOB BONE CMT R-3

    MDR report key: 24266473 · Received February 5, 2026

    Report

    Report Number
    3006946279-2026-00006
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    July 8, 2025
    Report Date
    February 5, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    04040029922347
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304990197. D10: ITEM NUMBER#: 00598604701, ITEM NAME#: STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5 FOR CEMENTED USE ONLY, LOT#: 64129614. ITEM NUMBER#: 00596601702, ITEM NAME#: CRUCIATE RETAINING (CR) FEMORAL COMPONENT OPTION SIZE G RIGHT FOR CEMENTED USE ONLY, LOT#: 63701739. ITEM NUMBER#: 90597004012, ITEM NAME#: ARTICULAR SURFACE, LOT 64242383. ITEM NUMBER#: 4711500396-3, ITEM NAME#: OPTIPAC 60 REFOB BONE CMT R-3, LOT#: 836BA01425. ITEM NUMBER#: 00625006520, ITEM NAME#: BONE SCREW SELF TAPPING 6.5 MM DIA. 20 MM LENGTH, LOT#: 64106453. ITEM NUMBER#: 00625006520, ITEM NAME#: BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH, LOT#: 64102119. G2 ¿ FOREIGN ¿ EUROPE: UNITED KINGDOM. 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 PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, APPROXIMATELY 3 YEARS POST IMPLANTATION, PATIENT HAD DEVELOPED PAIN IN THE RIGHT KNEE, AND SAID THE KNEE NEVER FELT QUITE RIGHT. APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT DESCRIBED ANTERIOR KNEE PAIN ALONG WITH INSTABILITY. THE GENERAL PROVIDER INCREASED PATIENT'S PAIN MEDICATION AND REFERRED TO MUSCULAR SKELETAL CLINIC. APPROXIMATELY 6 YEARS POST IMPLANTATION, RADIOLOGICAL INVESTIGATIONS CONFIRMED LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT WAS SUBSEQUENTLY REVISED. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329927 OPTIPAC 40 REFOB BONE CMT R-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. 826DA09200 04040029922347

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention| H SEE H11 NARRATIVE.