BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 44MM F

    MDR report key: 24010326 · Received January 8, 2026

    Report

    Report Number
    0001825034-2026-00082
    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
    00880304703520
    PMA / PMN Number
    K150522
    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

    (B)(4). D10: UNKNOWN CUP. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H1; H2; H3; H4; H6; H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: THERE IS MALALIGNMENT OF THE INNER LINER AND ACETABULAR SHELL CONCERNING COMPONENT DISASSOCIATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR TRENDS.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390709 G7 DUAL MOBILITY LINER 44MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66841442 00880304703520

    Patients

    Seq Age Sex Outcome Treatment
    1