BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 5692057 · Received June 1, 2016

    Report

    Report Number
    1818910-2016-20391
    Event Type
    Injury
    Date Received
    June 1, 2016
    Date of Event
    May 16, 2016
    Report Date
    May 16, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

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

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH ON THE PROVIDED LOT NUMBERS (3179736 AND 3121337) FOUND ADDITIONAL REPORTS. A PREVIOUS DHR REVIEW (B)(4) ON THE REPORTED SMARTSET GHV GENTAMICIN 40G (PRODUCT CODE 545035500, LOT NUMBER 3179736) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (3121337). CORRECTIVE ACTION WAS NOT INDICATED. 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

    UPDATE REC'D 06/02/2016 AND 06/03/2016 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAS A RIGHT KNEE SCOPE DONE IN 2013 TO ADDRESS PATELLA CLUNK.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND PATELLA CREPITUS. LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DURING SURGERY, THE SURGEON NOTED THAT THE FEMORAL COMPONENT WAS OVERSIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347243 SMARTSET GHV GENTAMICIN 40G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 3179736

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention