BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLAIM ELBOW PIN ASSEMBLY

    MDR report key: 2992558 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13346
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDC
    PMA / PMN Number
    PK992656
    Removal / Correction Number
    Z-378/413-2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS INVESTIGATION WAS CONDUCTED FOR A SIMILAR EVENT AND 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

    THE PATIENT WAS REVISED BECAUSE THE PIN ASSEMBLY DISENGAGED AND THE YOKE WAS WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97562 ACCLAIM ELBOW PIN ASSEMBLY PIN ASSEMBLY JDC DEPUY ORTHOPAEDICS, INC. 1818910 ZS5AC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention