BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAN CMNTD SHELL SS 50MM

    MDR report key: 24128642 · Received January 21, 2026

    Report

    Report Number
    3002806535-2026-00022
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    December 30, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868524561
    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) D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304524309. D10: ITEM NAME# AVAN E1 INSERT 28 S 50; ITEM NUMBER# P0561E50; LOT # 0001802557. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 THE PATIENT UNDERWENT A REVISION DUE TO PROSTHESIS DISLOCATION. THE DISLOCATION WAS ATTRIBUTED TO COMPRESSIVE FORCES FROM A LARGE CHONDROSARCOMA ACTING ON THE IMPLANT, AND THE PRIOR ACETABULAR COMPONENT WAS REMOVED AND EXCHANGED FOR A CEMENTED ALL-POLYETHYLENE CUP. APPROXIMATELY 1 YEAR, 2 MONTHS, AND 15 DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100108 AVAN CMNTD SHELL SS 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. 0001817425 00887868524561

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Hospitalization| R SEE H11 NARRATIVE