BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY BEARING

    MDR report key: 1930989 · Received December 14, 2010

    Report

    Report Number
    1818910-2010-09777
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    January 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY REPORTED AS 18 YRS AGO. THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED TO EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR BASED ON THE LACK OF THE PRODUCT TO EXAMINE; HOWEVER, WEAR OF A POLYETHYLENE KNEE DEVICE AFTER EIGHTEEN YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY BEARING TOTAL KNEE REPLACEMENT JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention