BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC PLI 15MM SZ3

    MDR report key: 1071255 · Received July 7, 2008

    Report

    Report Number
    1818910-2008-02658
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED IMPLANTATION WAS 18 YEARS AGO. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION; HOWEVER, INFECTION AFTER 18-YEARS IMPLANTATION IS UNLIKELY TO BE PRODUCT RELATED. THE REPORTED POLYETHYLENE WEAR WAS CONFIRMED AND IS ATTRIBUTED TO WEAR OUT. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS MILD INFECTION, DEBRIDED KNEE AND REPLACED INSERT, POLYWEAR NOTED ON INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC PLI 15MM SZ3 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention