BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLUSTER-HOLE PRI SHELL W/SEALED SCWHLS

    MDR report key: 510465 · Received February 6, 2004

    Report

    Report Number
    2935620-2004-00012
    Event Type
    Injury
    Date Received
    February 6, 2004
    Date of Event
    December 11, 2003
    Report Date
    February 6, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT WAS REVISED IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLUSTER-HOLE PRI SHELL W/SEALED SCWHLS ORTHOPEDIC HIP IMPLANT LZO CENTERPULSE ORTHOPEDICS, INC. NA 1548944

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization (LOT#1543237)(2003), 4376-32-053 SZ 32/53MM STD| INS DURASUL EPSILON (LOT#1546539)(2003).| 7210-32-400 COCR HD 12/14 +4 MM NECK 32MM