BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMA*CEM ST COLLESS/10/12SZ2

    MDR report key: 2919572 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11092
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 1, 2005
    Report Date
    January 10, 2013
    Manufacturer
    DEPUY SYNTHES
    Product Code
    KWL
    PMA / PMN Number
    PK900638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE REQUESTED INFORMATION FOR MANUFACTURING DATES IS AS FOLLOWS: A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER 661514, PRODUCT CODE 853572 IDENTIFIED THE MANUFACTURING DATE AS JUNE 1999. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER 619864, PRODUCT CODE 851881 AND LOT NUMBER 369153, PRODUCT CODE 859756 COULD NOT BE CARRIED OUT AS THE RECORDS COULD NOT BE FOUND. BASED UPON THE FACT THAT LOT NUMBER 661514 WAS MANUFACTURED IN JUNE 1999 AND THE OTHER TWO LOT NUMBERS ARE SEQUENTIALLY OLDER THAN THIS THEN WE CAN DETERMINE THAT THE OTHER TWO BATCHES WERE MANUFACTURED PRIOR TO JUNE 1999. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION UNTIL FURTHER INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PINNACLE MOM REVISION. REASON NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26893 ULTIMA*CEM ST COLLESS/10/12SZ2 FEMORAL STEM KWL DEPUY SYNTHES 661514

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention