BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA MKT MOD PATELLA CLAMP CAP

    MDR report key: 2002070 · Received February 4, 2011

    Report

    Report Number
    2249697-2011-00129
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING CEMENTING OF THE PATELLA, THE PATELLA CLAMP WAS TIGHTENED DOWN ON TO THE PATELLA, THE CEMENT CAP PIECE SNAPPED OFF AND FELL TO THE FLOOR. SURGERY WAS COMPLETED AS PLANNED USING ANOTHER ITEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MKT MOD PATELLA CLAMP CAP INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other