BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK G7 CUP

    MDR report key: 23220283 · Received October 6, 2025

    Report

    Report Number
    0001825034-2025-03097
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    June 5, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D.4.: ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. D.10.: CAT: 00811400218, LOT: 65514628 FEMORAL STEM. CAT: 00877704004, LOT: 3052345 BIOLOX® OPTION, HEAD, XL. G2: FOREIGN ¿ AUSTRALIA. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE EXPLANTED CERAMIC HEAD AND SHELL WITH BIO-DEBRIS ON THE DEVICES. NO FURTHER EVALUATION CAN BE MADE USING THE IMAGE ALONE. PICTURES WERE NOT PROVIDED FOR THE STEM AND LINER. NO PRODUCT WAS RETURNED; FURTHER VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED FOR THIS SPECIFIC REVISION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT CONFIRMED. 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 FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2654181 UNK G7 CUP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H