BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CEMENT

    MDR report key: 1454816 · Received August 19, 2009

    Report

    Report Number
    1818910-2009-04354
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    July 22, 2009
    Report Date
    July 22, 2009
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND SEARCH THE COMPLAINT DATABASE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCTS TO EXAMINE AND INSUFFICIENT CEMENT PRODUCT INFORMATION. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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

    PATIENT WAS REVISED TO ADDRESS PAIN AFTER A FALL. INTRAOPERATIVELY DISCOVERED THAT THE CEMENT HAD NOT BONDED TO THE IMPLANT OR BONE.

    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 69 YR Required Intervention