BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 RINGLOC BIPOLAR 28X43MM

    MDR report key: 5741685 · Received June 22, 2016

    Report

    Report Number
    0001825034-2016-02213
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    December 15, 2015
    Report Date
    May 31, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HBE
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051569. (B)(4). EXAMINATION OF PHOTOGRAPH OF DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE AND CONFIRMED THE REPORTED CONDITION. ROOT CAUSE WAS DETERMINED TO BE TRAINED OPERATOR ERROR. FURTHER INVESTIGATION WAS INITIATED TO ADDRESS THE REPORTED ISSUE. IT WAS DEEMED NO FURTHER ACTIONS NECESSARY.

    Description of Event or Problem · 1

    DURING A PROCEDURE, BURRS WERE FOUND ON THE POLY LINER RIM BEFORE IMPLANTATION. THE BURRS WERE REMOVED FROM THE LINER AND THE LINER WAS CLEANED. THE LINER WAS USED TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397051 E1 RINGLOC BIPOLAR 28X43MM PROSTHESIS, HIP HBE BIOMET ORTHOPEDICS N/A 684930

    Patients

    Seq Age Sex Outcome Treatment
    1