BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 BONEMASTER

    MDR report key: 23183360 · Received September 30, 2025

    Report

    Report Number
    0001825034-2025-03060
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 650-1158 LOT: 3050886 DELTA CER FEM HD 28/0MM T1. G2: FOREIGN ¿ AUSTRALIA . G4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO 510(K) CAN BE DETERMINED. THE DEVICE IS CONSIDERED SIMILAR TO PRODUCT # 010000663 AND 510(K) K121874. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINCE THE HARD BEARING LINER AND SHELL DESIGNED FOR LONGEVITY, THE WELL-CONNECTED HARD BEARING LINER IS A DESIRED ASPECT OF THE PRODUCT. IN THE EVENT THAT A SURGEON DECIDES TO RE-USE A WELLFIXED SHELL, OPTIONAL INSTRUMENTS ARE PROVIDED TO ASSIST IN DOING SO. HOWEVER, IT IS UNDERSTOOD THAT THESE INSTRUMENTS MAY NOT PRODUCE THE DESIRED EFFECT EVERY TIME AND COMPLETE REMOVAL OF THE ACETABULAR ASSEMBLY MAY BE NECESSARY. 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 THREE YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO ONGOING PAIN IN DEEP FLEXION ANTERIOR TO THE HEAD. ATTEMPTS WERE MADE TO INJECT THE REGION WHERE THE PAIN IS AND THE PATIENT STILL COMPLAINED OF ONGOING PAIN. THE DECISION WAS MADE TO OPEN THE HIP AND REMOVE AS MUCH SCAR TISSUE AND WASH OUT THE JOINT. THE LINER WAS UNABLE TO BE REMOVED FROM THE CUP SO THE CUP WAS ALSO REMOVED. A LARGER CUP WAS IMPLANTED AND REORIENTED TO GAIN MORE ANTEVERSION IN HOPES OF REDUCING IMPINGEMENT; THE PREVIOUS CUP WAS IN ZERO DEGREES ANTEVERSION. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837110 G7 BONEMASTER PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. 7218370

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Required Intervention| H