BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY 1 GENTAMICIN CEMENT 40G

    MDR report key: 2052556 · Received April 11, 2011

    Report

    Report Number
    1818910-2011-06198
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    MBB
    PMA / PMN Number
    K053002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE FOR THE REQUIRED FOR THE CEMENT WAS NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE FEMORAL PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF FEMORAL COMPONENT AT CEMENT/BONE INTERFACE. DEPUY 1 CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention