BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV ENDURANCE 80G

    MDR report key: 5028642 · Received August 25, 2015

    Report

    Report Number
    1818910-2015-28941
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    PMA / PMN Number
    PK033382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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).

    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 ATTUNE FB TIB BASE SZ 6 CEM (PRODUCT CODE 150600006, LOT NUMBER 7787650) 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. CORRECTIVE ACTION WAS NOT INDICATED. THE RETAINED SAMPLES FOR SMARTSET MV ENDURANCE, PC:3102080, LOT:7868183 WERE TESTED FOR DOUGH TIME, SETTING TIME, HANDLING CHARACTERISTICS AND MECHANICAL PROPERTIES. THE FMEA AND IFU HAVE BOTH BEEN REVIEWED. IMPLANT LOOSENING IS A KNOWN RISK WITH THE USE OF BONE CEMENTS AND THE RISK IS HIGHLIGHTED IN BOTH DOCUMENTS. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL TRAY LOOSENING. LOOSENING OCCURRED AT THE BONE/CEMENT INTERFACE. CEMENT WAS MANUFACTURED BY DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560588 SMARTSET MV ENDURANCE 80G CEMENT / CEMENT ACCESSORY LOD DEPUY ORTHOPAEDICS INC US 7868183

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention ATTUNE MEDIAL DOME PAT 41MM| ATTUNE PS FB INSRT SZ 7 5MM| ATTUNE PS FEM RT SZ 7 CEM