BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CEMENT

    MDR report key: 1456701 · Received August 26, 2009

    Report

    Report Number
    1818910-2009-05024
    Event Type
    Injury
    Date Received
    August 26, 2009
    Date of Event
    August 25, 2009
    Report Date
    August 25, 2009
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVIEW OF THE INFORMATION PROVIDED, AS THE PART AND LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. PROVIDED INFO STATES THE PT WAS ACTIVE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION 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 AT THE CEMENT/BONE INTERFACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention