BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 4953954 · Received July 30, 2015

    Report

    Report Number
    1818910-2015-26977
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK090622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). (B)(6), 2015.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. (B)(4) HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A PATELLA TENDON RUPTURE AND TIBIAL LOOSENING. LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. CEMENT WAS MANUFACTURED BY DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496671 SMARTSET GMV 40G US EO CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 7786071

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention