BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL CR IMPACTOR PAD

    MDR report key: 8306818 · Received February 5, 2019

    Report

    Report Number
    0001822565-2019-00455
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 11, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K172524
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE VISUAL EVALUATION OF IMPACTOR PAD LOT 62658607 EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) AND HAS FRACTURED. BASED ON THE RESEARCH MEMO ZMR-WA-0507-19, THE FRACTURE IN THE IMPACTOR PAD IS RELATED TO OVERLOAD FAILURE OR LOW CYCLE FATIGUE CULMINATING IN THE OVERLOAD FAILURE. THIS INFORMATION CONFIRMS THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE SUPPLIER DHR CANNOT BE REVIEWED SINCE THE SUPPLIER IS OUT OF BUSINESS REF: IE-02842. PER PACKAGE INSERT (87-6203-991-22 INSTRUMENT/ PROVISIONAL USE, CARE AND STERILIZATION) INSPECT ALL INSTRUMENTS/PROVISIONAL CAREFULLY PRIOR TO EACH USE. IF DAMAGE OR WEAR IS NOTED THAT MAY COMPROMISE THE FUNCTION OF THE INSTRUMENT, DO NOT USE THE DEVICE AND CONTACT YOUR ZIMMER REPRESENTATIVE FOR A REPLACEMENT; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). FOREIGN SOURCE- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING A PROCEDURE. NO PIECES OF THE INSTRUMENT FELL INTO THE PATIENT'S WOUND. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98095 FEMORAL CR IMPACTOR PAD PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI 62658607

    Patients

    Seq Age Sex Outcome Treatment
    1