BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P.F.C.* MOD TIB TRAY SZ-3N N-8

    MDR report key: 3324368 · Received September 4, 2013

    Report

    Report Number
    1818910-2013-26064
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    August 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    DEPUY ORTHOAPEDICS INC
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. PATIENT¿S LEFT KNEE WAS REVISED TO ADDRESS OSTEOLYSIS ABOUT 15 YEARS AFTER PRIMARY IMPLANTATION. POLY WEAR AND LOOSENING WERE ALSO REPORTED. THE X-RAY IMAGES SHOW LITTLE TO NO VISIBLE GAP BETWEEN THE FEMORAL COMPONENT AND THE TIBIAL TRAY INDICATING SUBSTANTIAL POLY WEAR. THE PHOTO OF THE PFC INSERT CONFIRMS THAT IT EXPERIENCED SEVERE WEAR WHICH IS LIKELY NOT ABNORMAL CONSIDERING ITS 15 YEARS IN VIVO. LARGE RADIOLUCENT AREAS ARE VISIBLE ANTERIOR AND MEDIAL TO THE TIBIAL TRAY STEM AS WELL AS SUPERIOR TO THE FEMORAL COMPONENT. THE PATIENT X-RAYS AND PHOTOS OF THE EXPLANTED INSERT CONFIRM THE PRESENCE OF OSTEOLYSIS REPORTED IN THE COMPLAINT. THE ANTERIOR FEMORAL FLANGE HAS A RADIOLUCENT GAP AT THE BONE/IMPLANT INTERFACE, AND THERE APPEARS TO BE A THIN RADIOLUCENT BORDER AROUND THE TIBIAL TRAY IN THE A-P VIEW. GIVEN THESE FINDINGS AND THE OVERALL POOR BONE QUALITY SURROUNDING THE IMPLANTED DEVICES, THIS IS CONSISTENT WITH THE REPORTED LOOSENING. ADDITIONAL EVENT INFORMATION AND INVESTIGATIONAL INPUTS WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED,

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    BECAUSE OF POLY INSERT WORN OUT, OSTEOLYSIS FOUND AROUND THE IMPLANTS AND IMPLANTS WERE LOOSE ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437264 P.F.C.* MOD TIB TRAY SZ-3N N-8 TIBIAL TRAY JWH DEPUY ORTHOAPEDICS INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention