BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAVE ACTIVE PFC OVPAT38MM STD

    MDR report key: 1033941 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01250
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K935262
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT CONFIRM THE REPORTED "PATELLA WAS FREE-FLOATING IN JOINT; HOWEVER, EVIDENCE WAS FOUND OF PREFERENTIAL LOADING OF THE PATELLA ONTO THE FEMORAL COMPONENT, WHICH COULD CONTRIBUTE TO LOSS OF FIXATION OF THE PATELLA COMPONENT. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY WAS NOT PROVIDED. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. IN ADDITION, THE PRODUCT CODES ARE OBSOLETE ITEMS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATELLA WAS FREE FLOATING IN JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAVE ACTIVE PFC OVPAT38MM STD 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention