BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM KEEL TIB TRAY SZ3

    MDR report key: 2231495 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17117
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    DEPUY IRELAND
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REVIEW OF THE AS400 SYSTEM SHOW THAT 19 OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND/OR INVOICED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE AS NO FURTHER REPORTS ARE IDENTIFIED. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    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 REVISED FOR PAIN AND LOOSE TIBIAL TRAY AT CEMENT/IMPLANT. CEMENT MANUFACTURED BY OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM KEEL TIB TRAY SZ3 KNEE NJL DEPUY IRELAND 3103511

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention