BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LCS LG+ CRUCIFORM METAL-BACKED PATELLA

    MDR report key: 2549677 · Received April 26, 2012

    Report

    Report Number
    1818910-2012-11001
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A WORN, FRACTURED PATELLA POLY. IT WAS NOTED THAT THE PATELLA FRACTURED INTO TWO PIECES WHILE PATIENT WAS FLEXING KNEE DURING A ROUTINE EXAMINATION. (RIGHT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY LCS LG+ CRUCIFORM METAL-BACKED PATELLA KNEE IMPLANT JWH DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention