BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSERT SZ3 10MM

    MDR report key: 1954422 · Received January 5, 2011

    Report

    Report Number
    1818910-2010-10797
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    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. PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. 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 AND THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSERT SZ3 10MM TIBIAL INSERT JWH DEPUY RAYNHAM NA 955251

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention