BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 5694658 · Received June 2, 2016

    Report

    Report Number
    1818910-2016-20477
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    PMA / PMN Number
    PK033563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. QTY 2. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH ON THE PROVIDED SMARTSET GHV GENTAMICIN 40G (PRODUCT CODE 545035500, LOT NUMBER 2137409) FOUND ADDITIONAL REPORTS AND A DHR REVIEW WAS CONDUCTED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (2137409). 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

    PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE AND LOOSENING. LOOSENING OCCURRED AT BOTH INTERFACES. DEPUY CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350321 SMARTSET GHV GENTAMICIN 40G CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 2137409

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention