BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GMV 40G US EO

    MDR report key: 2851308 · Received November 29, 2012

    Report

    Report Number
    1818910-2012-28423
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    DEPUY CMW
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    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

    UPDATE: 9/4/2012 - A SUBSET OF THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. PATIENT X-RAYS HAVE ALSO BEEN RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD REQUIRED UPDATE TO THE EXISTING MDR DECISION. UPDATED: 02/07/2013: IN ADDITION TO PATIENT RECORDS, PATIENT X-RAYS HAVE ALSO BEEN RECEIVED AND THE INVESTIGATION CORRECTED. THE DEVICE ASSOCIATED WITH THIS REPORT HAS STILL NOT BEEN PROVIDED FOR EXAMINATION. AS WITH THE EARLIER INVESTIGATION THERE ARE NO ADDITIONAL REPORTS AGAINST LOT 2269915. EXAMINATION OF THE PROVIDED PATIENT RECORDS AND X-RAYS BY A DEPUY (B)(4). DID NOT IDENTIFY A ROOT CAUSE OR IDENTIFY A NEED FOR CORRECTIVE ACTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENTS AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. INFECTION WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GMV 40G US EO BONE CEMENT MBB DEPUY CMW 3310547

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention