BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO-FLEX PS X3 TIB INSERT

    MDR report key: 1132054 · Received August 21, 2008

    Report

    Report Number
    2249697-2008-00246
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 1, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSH
    PMA / PMN Number
    K051977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN. IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; "IN 2008, A PT GOT THE PRIMARY SURGERY AND A PT VISITED HOSPITAL ON THE FOLLOWING MONTH, AGAIN. DR. FOUND OUT PT'S KNEE HAS M/L LAXITY AND SHOWS HYPEREXTENSION SOMEWHAT. DR. DID REVISION SURGERY AND FOUND OUT INSERT WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX PS X3 TIB INSERT IMPLANT HSH STRYKER ORTHOPAEDICS MAHWAH NA 11SCW

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention