BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BISPHERICAL SHELL 50D

    MDR report key: 23801032 · Received December 15, 2025

    Report

    Report Number
    3002806535-2025-00614
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    September 4, 2025
    Report Date
    May 12, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    05019279515684
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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). D10: ITEM NAME# G7 NEUTRAL E1 LINER 32MM D; ITEM NUMBER# 010000848; LOT# 6334937. ITEM NAME# DELTA CER FEM HD 32/-3MM T1; ITEM NUMBER# 650-1163; LOT# 2019091998. ITEM NAME# TAPERLOC COMPLETE PPS, REDUCED DISTAL 10 140; ITEM NUMBER# 51103100; LOT# 6543127. G2: FOREIGN - EVENT OCCURRED IN NETHERLANDS. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K101336. 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 UNDERWENT HIP REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE CUP, APPROXIMATELY 5 YEARS, 7 MONTHS, AND 25 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
    612273 G7 BISPHERICAL SHELL 50D PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH BIOMET UK LTD. 6153403 05019279515684

    Patients

    Seq Age Sex Outcome Treatment
    1