BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ3, 11MM

    MDR report key: 25225325 · Received May 19, 2026

    Report

    Report Number
    1038671-2026-00627
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040251
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 200-02-32 - THREE PEG PATELLA 32MM: (B)(6). 200-04-33 - CEMENTED FINNED TIB. TRA SZ 3F/3T: (B)(6). 201-46-10 - HOLDING PIN HEADLESS 3" (4 PK): (B)(6). 230-03-03 - OPTETRAK ASY, CR CEMENTED FEMORAL, SZ 3: (B)(6). 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS: (B)(6). 620-11-02 - ACCELERATE CONC. SYS REP BY 620-12-02: (B)(6). 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 THE PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT REQUIRED A REVISION SURGERY DUE TO PAIN AND OSTEOLYSIS. THE PATIENT TOLERATED THE PROCEDURES WELL WITH NO REPORTED COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358321 CR TIBIAL INSERT SZ3, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862040251

    Patients

    Seq Age Sex Outcome Treatment
    1