BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC* PLI TIB INS SZ 5, 8MM

    MDR report key: 2875319 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-83820
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 14, 2012
    Report Date
    December 12, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. IT HAS NOT BEEN CONFIRMED THE PATIENT HAS BEEN REVISED TO DATE. ORIGINAL DATE OF IMPLANTATION WAS NOT PROVIDED TO CUSTOMER QUALITY. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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, THE INVESTIGATION WILL BE RE-OPENED.

    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

    THE PATIENT IS BOOKED FOR KNEE REVISION SURGERY ON (B)(6) 2012, DUE TO INFECTION. THE PATIENT HAS BEEN ADMITTED TO HOSPITAL. THERE ARE NO X-RAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC* PLI TIB INS SZ 5, 8MM DEPUY KNEE IMPLANT JWH DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention