BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C. CRUC SACR FEM SIZE-1

    MDR report key: 1030211 · Received April 16, 2008

    Report

    Report Number
    1818910-2008-01419
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K882234
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROX 15 YEARS AGO. EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE 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 OR DEVICE LOOSENING; HOWEVER, POLYETHYLENE WEAR AFTER APPROX FIFTEEN PLUS YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PRODUCT CODES ARE DISCONTINUED ITEMS. 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 WAS REVISED TO ADDRESS POLY WEAR OF THE INSERT, OSTEOLYSIS, AND LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P.F.C. CRUC SACR FEM SIZE-1 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention