BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 54MM F

    MDR report key: 24982180 · Received April 24, 2026

    Report

    Report Number
    0001825034-2026-01034
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    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: CAT# 00877504002, LOT# 3264121, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 40/0, TAPER 12/14 CAT# 574201030 LOT# 3210756 FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 3. CAT# 30104006, LOT# 67489040, 40MM I.D. SIZE F NEUTRAL LINER. G2: FOREIGN: AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. THE PATIENT WAS REVISED APPROXIMATELY TWO WEEKS LATER DUE TO MALPOSITION, INCORRECT SIZING, DISLOCATION AND INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473922 G7 OSSEOTI 4 HOLE SHELL 54MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 67524610

    Patients

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