BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS FEMUR WAFFLE POSTS W/LFIT

    MDR report key: 1163106 · Received September 16, 2008

    Report

    Report Number
    2249697-2008-00272
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    June 4, 2008
    Report Date
    August 20, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HSA
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DEVICE IS STILL IMPLANTED IN PT AND THEREFORE, IT IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. SHOULD DEVICE BECOME AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "TWO COMPLICATION FORMS WERE REC'D FROM THE SITE. ONE FORM INDICATED "PES TENDINITIS WITH CALCIFICATION IN THE MEDIAL COMPARTMENT"; PAIN OVER THE MEDIAL JOIN LINE; SEVERITY WAS MODERATE; RELATION TO THE DEVICE WAS MARKED "UNCERTAIN";TREATMENT CONSISTED OF "LIDOCAINE AND KENALOG INJECTIONS, PHYSICAL THERAPY X3; THE EVENT WAS UNRESOLVED AS OF 2008." THE SECOND COMPLICATION FORM INDICATED "INCREASED SWELLING"; MILD IN SEVERITY; RELATION TO DEVICE IS "UNCERTAIN"; NO TREATMENT AND UNRESOLVED AS OF 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS FEMUR WAFFLE POSTS W/LFIT IMPLANT HSA STRYKER ORTHOPAEDICS MAHWAH NA LTTMKA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention