BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC CNSTR22.5MMS3

    MDR report key: 2002834 · Received February 16, 2011

    Report

    Report Number
    1818910-2011-02529
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY MFG DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR WITHOUT THE PRODUCT TO EXAMINE. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR APPROX EIGHTEEN YEARS PRIOR TO REVISION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS A DISCONTINUED 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 FOR POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC CNSTR22.5MMS3 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 17Y9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention