BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM RECAP CUP 60ODX54ID

    MDR report key: 24756963 · Received April 1, 2026

    Report

    Report Number
    0001825034-2026-00802
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H10: M2A-MAGNUM MOD HD SZ 54MM. ITEM: 157454. LOT: 1222719. PPF LTZ STEM SZ 07X165MM. ITEM: 7100100307. LOT: 2006070180. MAGNUM TPR ADPR TI 52-60/-2MM MM12/14. ITEM: 130834. LOT: 1222434. G2: FOREIGN ¿ ITALY. THE CUSTOMER INDICATED THAT THE PRODUCT REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PSEUDOTUMORAL DEBRIS OF ABOUT 10 CM IN DIAMETER APPROXIMATELY 19 YEARS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT HAS AN IMPAIRMENT OF A BODILY FUNCTION. THE DEVICE IN QUESTION IS NOT AVAILABLE AS IT IS STILL IMPLANTED IN THE PATIENT (METAL-ON-METAL PROSTHESIS). IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814309 M2A-MAGNUM RECAP CUP 60ODX54ID PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 1093610

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Other