BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBP ELB INT. ULNA LRG RGT LNG STM

    MDR report key: 5748139 · Received June 24, 2016

    Report

    Report Number
    3002806535-2016-00383
    Event Type
    Injury
    Date Received
    June 24, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE IMPLANTED - NI, 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 MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K043505. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. REVISION WAS INDICATED DUE TO PATIENT ANATOMY AND THE FAILURE IS NOT PRODUCT OR PROCEDURE RELATED.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR RIGHT ELBOW REVISION PROCEDURE DUE TO LOOSENING OF THE ULNA COMPONENT. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403130 IBP ELB INT. ULNA LRG RGT LNG STM PROSTHESIS, ELBOW JDC BIOMET UK LTD. N/A 2328723

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention