BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBP ELBOW INTERLOK FINISH ULNAR COMPONENT STANDARD LEFT

    MDR report key: 6641122 · Received June 14, 2017

    Report

    Report Number
    3002806535-2017-00483
    Event Type
    Injury
    Date Received
    June 14, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDB
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K972691. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELBOW REVISION HAS BEEN INDICATED DUE TO LOOSENING OF THE ULNAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422109 IBP ELBOW INTERLOK FINISH ULNAR COMPONENT STANDARD LEFT PROSTHESIS, ELBOW JDB BIOMET UK LTD. N/A 1504733

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention