BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D

    MDR report key: 25069472 · Received May 4, 2026

    Report

    Report Number
    3007963827-2026-00161
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024471030
    PMA / PMN Number
    K172524
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN, FEMORAL COMPONENT, UNKNOWN. 42-5121-005-10, MC ARTICULAR SURFACE, 65130099. G2: FOREIGN - EVENT OCCURRED IN NEW ZEALAND. 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 THE PATIENT UNDERWENT AN INITIAL TKA. SUBSEQUENTLY, ABOUT 4 YEARS LATER THEY HAD A REVISION SURGERY DUE TO TIBIAL SUBSIDENCE AND LOOSENING. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593823 PERSONA TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64851491 00889024471030

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention| H SEE H11