BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,38

    MDR report key: 3000399 · Received March 12, 2013

    Report

    Report Number
    1818910-2013-04121
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    November 5, 2012
    Report Date
    February 12, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(6) 2013 - PATIENT'S X-RAYS WERE RECEIVED. COMPLAINT RE-OPENED. **UPDATE** (B)(6) 2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION OSTEOLYSIS AND POLY WEAR WERE FOUND, AND ALSO FEMORAL LOOSENING. THE COMPLAINT WAS RE-OPENED. THE DEVICE ASSOCIATED WITH THIS REPORT WAS STILL NOT RETURNED. A COMPLAINT DATABASE SEARCH OF THE NEWLY ADDED PRODUCTS FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THERE RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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

    CLINICAL REPORT STATES A REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT DOI: (B)(6) 2002, DOR: (B)(6) 2012 (LEFT KNEE). UPDATE PATIENTS X-RAYS WERE RECEIVED. COMPLAINT RE-OPENED. UPDATE 02/12/2013 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION OSTEOLYSIS AND POLWEAR WERE FOUND, AND ALSO FEMORAL LOOSENING. THE COMPLAINT WAS RE-OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104028 PFC*SIGMA/OV/DOME PAT 3PEG,38 PATELLAR JWH DEPUY RAYNHAM 296742

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention