BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY CEMENT

    MDR report key: 1181483 · Received September 26, 2008

    Report

    Report Number
    1818910-2008-04072
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. THE INVESTIGATION IS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS, COMPLAINTS DATABASE AND CONDUCT TESTING OF RETAINED SAMPLES HAS NOT BEEN PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PROD AND/OR ANY ADD'L INFO BE REC'D 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 THE TRAY AT THE CEMENT/BONE INTERFACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention