BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINKED BEARING ASSEMBLY

    MDR report key: 2112795 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08918
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDC
    PMA / PMN Number
    K992656
    Removal / Correction Number
    Z-531-6
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS INVESTIGATION FOUND THE ULNAR BEARING COMPONENT TO HAVE A MINIMAL CHAMFER THAT MAY LEAD TO PREMATURE POLYETHYLENE WEAR AT CERTAIN CONTACT POINTS. THE PREMATURE WEAR CAUSES THE POLYETHYLENE TO FAIL, WHICH MAY LEAD TO THE POTENTIAL FOR THE LOCKING PIN TO DISASSOCIATE FROM THE ELBOW ASSEMBLY. A VOLUNTARY RECALL FOR THE ULNAR BEARING COMPONENTS WAS INITIATED IN NOVEMBER OF 2005. IN ADDITION, A BUSINESS DECISION WAS MADE TO NO LONGER MARKET THE ELBOW. A VOLUNTARY MARKET WITHDRAWAL WAS ALSO INITIATED FOR THE OTHER PRODUCT CODES OF THE ACCLAIM ELBOW ASSEMBLY. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE, ON XRAYS, THE PIN APPEARED LOOSE. AFTER PERFORMING SURGERY, IT WAS APPARENT THAT THE POLY HAD WORN OUT AND HAD BROKEN, ALLOWING THE PIN TO LOOSEN AND COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINKED BEARING ASSEMBLY 87JDC JDC DEPUY ORTHOPAEDICS, INC. NA ZA6FL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention