BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL BALL HEAD 28/0MM

    MDR report key: 24362450 · Received February 17, 2026

    Report

    Report Number
    0009613350-2026-00066
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 17, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: CONCOMITANT MEDICAL PRODUCTS: DESC: METASUL INSERT KK/28; ITEM: 4347; LOT: A892057, DESC: ALLOCLASSIC SL STEM 4 12/14; ITEM: 2844; LOT: B069195, DESC: AP ARMOR SHELL 56/KK; ITEM: 4207; LOT: B060638. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 EXPERIENCED MULTIPLE DISLOCATIONS. SUBSEQUENTLY, THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423302 METASUL BALL HEAD 28/0MM PROSTHESIS, HIP LPH ZIMMER GMBH B069195

    Patients

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