BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    MDR report key: 24268518 · Received February 5, 2026

    Report

    Report Number
    0001825034-2026-00299
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 5, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355899
    PMA / PMN Number
    K140669
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00625006530, LOT# J7341383 BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH. CAT# 30103606, LOT# 65983432 36MM I.D. SIZE F NEUTRAL LINER. CAT# 00-8775-036-01, LOT# 3140925 BIOLOX DELTA HD 12/14 36X-3.5. 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 AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO ILIOPSOAS PAIN FROM CUP OVERHANG DUE TO LACK OF MEDIALIZATION. DURING THE REVISION, THE CUP WAS REVISED AND DECREASED THE EXPOSED CUP ANTEROSUPERIOR. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330028 G7 OSSEOTI 4 HOLE SHELL 54MM F PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET, INC. 65649226 00887868355899

    Patients

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