BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/R NPOR FEM RT SZ 4

    MDR report key: 1954418 · Received January 5, 2011

    Report

    Report Number
    1818910-2011-00055
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K943462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE NEWLY PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. 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 THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE LACK OF THE PRODUCT TO EXAMINE AND INSUFFICIENT PRODUCT INFO. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS OSTEOLYSIS, POLY WEAR, AND FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC*SIGMA C/R NPOR FEM RT SZ 4 FEMORAL COMPONENT JWH DEPUY RAYNHAM NA 305755

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention