BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CEMENT, 2G

    MDR report key: 2122687 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09771
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE PRODUCT CODE AND LOT CODE REQUIRED TO SEARCH THE COMPLAINT DATABASE WAS NOT SUPPLIED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. PROVIDED INFORMATION STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. 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

    PT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO REPORTED THAT THE FEMORAL AND TIBIAL COMPONENTS WERE SLIGHTLY LOOSE AT THE CEMENT/BONE INTERFACE. DEPUY CEMENT WAS USED IN THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY CEMENT, 2G BONE CEMENT LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention