BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIA

    MDR report key: 25067562 · Received May 4, 2026

    Report

    Report Number
    0001822565-2026-01438
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 30, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 11-146134 - MAX PRI DCM TIB BRNG14X63/67MM - (B)(6). (B)(6) - MAXIM POR ANA PRI FML 60 LT - (B)(6). UNKNOWN - UNKNOWN TIBIA STEM - UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN INITIAL KNEE SURGERY AT UNKNOWN TIME. SUBSEQUENTLY AN UNKNOWN REVISION WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148530 UNKNOWN TIBIA PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11