BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET MV ENDURANCE 80G

    MDR report key: 5569787 · Received April 12, 2016

    Report

    Report Number
    1818910-2016-17166
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 5, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PP96001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION, HOWEVER REVIEW OF THE PROVIDED X-RAYS AND EXPLANT PHOTOGRAPH CONFIRMS THE REPORTED TIBIAL LOOSENING. 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.

    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 WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

    Description of Event or Problem · 1

    UPDATE REC'D 04/18/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS EXPERIENCING PERSISTENT PAIN. AT THIS TIME THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 05/11/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225092 SMARTSET MV ENDURANCE 80G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 7961087

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention