BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV 40G - EO

    MDR report key: 5270825 · Received December 7, 2015

    Report

    Report Number
    1818910-2015-36786
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 18, 2015
    Report Date
    November 30, 2015
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK081155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH FOUND PREVIOUS REPORTS ON THE SMARTSET MV 40G - EO. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT AND LOT COMBINATION. 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 40G - EO, (B)(4), LOT:23334281 COULD BE NOT BE TESTED AS IT HAS BEEN IDENTIFIED AS BEING OVER 4 YEARS OLD AND THE RETAINED SAMPLES HAVE EXPIRED RETENTION IN ACCORDANCE WITH THE DEPUY RETAINED SAMPLE PROCEDURE (B)(4). THE DFMEA AND IFU HAVE BOTH BEEN REVIEWED FOR THE CEMENT. 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.

    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).

    Description of Event or Problem · 1

    CLINICAL DER STATES PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE BONE/CEMENT INTERFACE. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802271 SMARTSET MV 40G - EO CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 3334281

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention