BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 LONGEVITY NEUTRAL 36MM F

    MDR report key: 23223161 · Received October 6, 2025

    Report

    Report Number
    0001822565-2025-03662
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    January 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518759
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CER BIOLOXD OPTION HD 36 MM. ITEM: 650-1057. LOT: 3234032. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WAS DISCARDED; 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 WHEN THE CUP AND NEUTRAL LINER WERE IMPLANTED AND TRAILED, THE PATIENT DISLOCATED. SUBSEQUENTLY, THE SURGEON CHOSE TO DISCARD THE NEUTRAL LINER AND IMPLANT A HIGH WALL LINER TO ENSURE PATIENT SAFETY. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2574835 G7 LONGEVITY NEUTRAL 36MM F PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 66918458 00889024518759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11