BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 4 HOLE SHELL 56MM F

    MDR report key: 24010397 · Received January 8, 2026

    Report

    Report Number
    0001825034-2026-00083
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 18, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355905
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6B: REMAINS IMPLANTED. THE CUSTOMER INDICATED THAT THE PRODUCT REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: G7 DUAL MOBILITY LINER 44MM F ITEM: 110024464 LOT: 66841442. BIOLOX® OPTION, HEAD, M, ø 28/0, TAPER 12/14 ITEM: 00877702802 LOT: 3192295. 28MM I.D. 44MM O.D. SIZE F BEARING ITEM: 110031012 LOT: 66603526. FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 4 ITEM: 574201040 LOT: 3191221. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH ITEM: 00625006535 LOT: 65829151. THE CUSTOMER INDICATED THAT THE PRODUCT LOCATION IS UNKNOWN; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1-YEAR POST IMPLANTATION DUE TO THE DUAL MOBILITY LINER LOOSENING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477448 G7 OSSEOTI 4 HOLE SHELL 56MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66744725 00887868355905

    Patients

    Seq Age Sex Outcome Treatment
    1