BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC PLI 8MM SZ5

    MDR report key: 1003577 · Received February 25, 2008

    Report

    Report Number
    1818910-2008-00732
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR; HOWEVER, POLYETHYLENE WEAR AFTER TWENTY YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS AN OBSOLETE ITEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC PLI 8MM SZ5 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention