BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAN CMNTD SHELL SS 50MM

    MDR report key: 24976927 · Received April 24, 2026

    Report

    Report Number
    3002806535-2026-00159
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    03599870013090
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K121874. 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 UPON OPENING THE STERILE PACKAGING OF A CUP, MATERIAL RESEMBLING A RED STICKER WAS OBSERVED ADHERED TO THE CUP SURFACE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CUP. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83838 AVAN CMNTD SHELL SS 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. 0001920703 03599870013090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown