BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KUDO ELBOW

    MDR report key: 6313747 · Received February 9, 2017

    Report

    Report Number
    3002806535-2017-00063
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    September 20, 2011
    Report Date
    March 23, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDB
    PMA / PMN Number
    PK972691
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE ARTICLE WAS WRITTEN BY ROTINI R, BETTELLI G, CAVACIOCCHI M, SAVARINO L. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K972691. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2017-00063 / 00066).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REVISION OF A LEFT ELBOW ARTHROPLASTY DUE TO PAIN AND PSEUDOTUMOR 16 YEARS POST-IMPLANTATION. THE PSEUDOTUMOR CAUSED DISLOCATION OF THE ULNAR NERVE. THIS NERVE WAS DAMAGED DURING THE REVISION AND REMOVAL OF THE PSEUDOTUMOR.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION OF A LEFT ELBOW ARTHROPLASTY DUE TO PAIN, PSEUDOTUMOR, PROSTHESIS LOOSENING, AND WEAR APPROXIMATELY 16 YEARS POST-IMPLANTATION. THE PSEUDOTUMOR CAUSED DISLOCATION OF THE ULNAR NERVE. THIS NERVE WAS DAMAGED DURING THE REVISION AND REMOVAL OF THE PSEUDOTUMOR. IT WAS FURTHER REPORTED THE PATIENT WAS ACTIVE AND PERFORMED HEAVY LABOUR WITH THE OPERATED ARM. THESE CONDITIONS CONTRIBUTED TO THE FAILURE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102147 UNKNOWN KUDO ELBOW PROSTHESIS, ELBOW JDB BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R| S