BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7

    MDR report key: 23480298 · Received November 5, 2025

    Report

    Report Number
    0001825034-2025-03481
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 29, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304526419
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 802203603 LOT# 3173489 FEMORAL HEAD. G2: FOREIGN ¿ NEW ZEALAND. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6. THE FOLLOWING SECTIONS WERE CORRECTED: B5 CORRECT TO NINETEEN MONTHS. 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 SEVEN MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TOO MUCH OFFSET AND JOINT TIGHTNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY NINETEEN MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TOO MUCH OFFSET AND JOINT TIGHTNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15454 G7 PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. R7315420A 00880304526419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H