BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY1 GENTAMICIN CEMENT 40G

    MDR report key: 1983468 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01437
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K023103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADD'L REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF IMPLANTATION. THE TIBIAL INSERT ALSO HAD SOME WEAR ON BOTH SIDES, AND A LARGE GOUGE ON THE POSTERIOR MEDIAL ASPECT. IT WAS NOTED THAT THE PT DESCRIBED AN INCIDENT WHERE SHE "TWEAKED" HER KNEE RECENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY1 GENTAMICIN CEMENT 40G 87LOD LOD DEPUY CMW NA E297GA40

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention