BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG C/R POROCOAT FEM LT SZ 3

    MDR report key: 2993031 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-13401
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JWH
    PMA / PMN Number
    PK062654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS FOR THE SIG MOD TIB TRAY CEM OR THE SIGMA XLKCVD PLUS INS SINCE THEIR RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE SIG C/R POROCOAT FEM AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE; HOWEVER IT WAS STATED IN THE INITIAL REPORTING THAT THE PATIENT'S PAIN WAS DUE TO HEAVY MANUAL LABOR. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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

    PATIENT WAS REVISED TO ADDRESS PAIN, WHICH WAS REPORTEDLY DUE TO HEAVY MANUAL LABOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98268 SIG C/R POROCOAT FEM LT SZ 3 FEMORAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention