BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLAIM ELBOW PIN ASSEMBLY

    MDR report key: 1024360 · Received April 2, 2008

    Report

    Report Number
    1818910-2008-01235
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDC
    PMA / PMN Number
    K992656
    Removal / Correction Number
    Z-378/413-2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND SEARCH THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THIS INVESTIGATION'S FINDINGS, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. ALTHOUGH THIS INVESTIGATION DID NOT ESTABLISH THE NEED FOR CORRECTIVE ACTION, A PREVIOUS INVESTIGATION WAS CONDUCTED FOR A SIMILAR EVENT AND IDENTIFIED A VOLUNTARY RECALL FOR THE ULNAR BEARING COMPONENTS WAS INITIATED IN 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 IN THE ACCLAIM ELBOW ASSEMBLY. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE THE YOKE WAS WORN AND THE PIN ASSEMBLY WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ELBOW PIN ASSEMBLY 87 JDC & 87JDB JDC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention