BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO-FLEX PS TIBIAL TRIAL

    MDR report key: 1958666 · Received December 16, 2010

    Report

    Report Number
    2249697-2010-01776
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    2249697-07/26/10-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR ADD'L DEVICES OF THE CATALOG #T72-5-1108A WERE ALSO REPORTED WITH THE FOLLOWING LOT #: PPMYC07, PPWE54; PPMYN03 AND PPMXW05. DEVICE MANUFACTURE DATE FOR LOT # PPMYC07: 02/13/2004. DEVICE MANUFACTURE DATE FOR LOT # PPWE54: 01/24/2003. DEVICE MANUFACTURE DATE FOR LOT # PPMYN03: 01/27/2005. DEVICE MANUFACTURE DATE FOR LOT # PPMXW05: 12/30/2003. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS STRYKER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THESE PRODUCTS DID NOT PASS THE INSPECTION FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX PS TIBIAL TRIAL INSTRUMENT JWH STRYKER ORTHOPAEDICS MAHWAH NA PPMXL11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other