BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM FINN MODULAR PROXIMAL FEMORAL COMPONENT RIGHT 7CM

    MDR report key: 22183234 · Received June 11, 2025

    Report

    Report Number
    0001825034-2025-01682
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 16, 2025
    Report Date
    July 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304239784
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT 17CM CATALOG #: 150471, LOT #: 66735386; ORTHOPEDIC SALVAGE SYSTEM CEMENTED PROXIMAL TIBIAL STEM 13MM X 150MM CATALOG #: 150446 LOT #: 281560; BIOMET MODULAR HEAD COMPONENT CATALOG #: 163669 LOT #: J7611326; CABLE-READY GRIP SYSTEM CERCLAGE CABLE WITH CRIMP 1.8MM X 25IN CATALOG #: 00223200418 LOT #: 67142058; CABLE-READY GRIP SYSTEM CERCLAGE CABLE WITH CRIMP 1.8MM X 25IN CATALOG #: 00223200418 LOT #: 66872104. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN AUSTRALIA. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED AS MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED DEVICE. STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESSES FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS THAT MAY INCLUDE HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER-RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. THE ROOT CAUSE WAS DETERMINED TO BE TRACED TO NON-DEVICE RELATED FACTORS. 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 THE PATIENT UNDERWENT A HIP ARTHROPLASTY REVISION TO TREAT INFECTION APPROXIMATELY SIX (6) WEEKS POST-OPERATIVELY. ALL COMPONENTS WERE REVISED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94389 ORTHOPEDIC SALVAGE SYSTEM FINN MODULAR PROXIMAL FEMORAL COMPONENT RIGHT 7CM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 65779772 00880304239784

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| H SEE H11 NARRATIVE