BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSETMV MV ENDURANCE 40 G (2 EACH)

    MDR report key: 2142744 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11117
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    P960001/S005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. DEPUY (B)(4) WAS UNABLE TO RETEST THE RETAINED SAMPLE OF THIS PRODUCT, IT WAS MANUFACTURED IN MAY 2007 (EXPIRY DATE APRIL 2010) AND THEREFORE IS MORE THAN 4 YEARS OLD AND HAS EXPIRED RETENTION, IN ACCORDANCE WITH THE QUALITY RETAINED SAMPLE PROCEDURE (SCPQC-01). ALTHOUGH THERE ARE NO RETAINED SAMPLES FOR THIS COMPLAINT, A PREVIOUS COMPLAINT FOR THIS PART AND LOT NUMBER FOUND THE RETAINED CEMENT SAMPLES WERE CONDITIONED AND TESTED AT AN AMBIENT TEMPERATURE OF 23 DEGREES C. ALL HANDLING AND MECHANICAL STRENGTH RESULTS WERE REVIEWED AND WERE WITHIN SPECIFICATION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH THE FEMORAL AND TIBIAL TRAY PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE 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.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSETMV MV ENDURANCE 40 G (2 EACH) 87 LOD LOD DEPUY CMW NA 2354787

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention