BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO TS MOD. TIB. TRAY

    MDR report key: 3120497 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01713
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K994128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE LISTED IN THIS REPORT IS CAT # 75-1-0705, LOT # TO5M253, SCORPIO TS DISTAL BLOCK. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY RESULTING FROM A FRACTURED OFFSET ADAPTER INVOLVING A SCORPIO BASEPLATE WAS REPORTED. THE RETURNED DEVICES INDICATED THE FEMORAL STEM FRACTURED. THERE IS NO ALLEGED FAILURE REGARDING THE BASEPLATE. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. UNKNOWN FEMORAL STEM AND UNKNOWN INSERT WERE ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. CAT. NO.: UNK, UNKNOWN FEMORAL STEM, LOT CODE: UNK. CAT. NO.: UNK, UNKNOWN INSERT, LOT CODE: UNK. CAT. NO.: 6478-6-585, OFFSET ADAPTOR 2MM REGULAR, LOT CODE: LCJFK1. CAT. NO.: 76-4107L, SCORPIO TS FEM. W/LFIT, LOT CODE: K05M437. CAT. NO.: 6478-6-630, TI DUR REG FLUTED STEM 16X80MM, LOT CODE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS STANDING AT WORK AND FELT A SHIFT IN HIS KNEE RESULTING IN EXCRUCIATING PAIN. PREVIOUS SURGERIES; PRIMARY IN 2005, FIRST REVISION IN 2007, WERE NOT AT THIS HOSPITAL, SO PAST REVISION INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS STANDING AT WORK AND FELT A SHIFT IN HIS KNEE RESULTING IN EXCRUCIATING PAIN. PREVIOUS SURGERIES; PRIMARY IN 2005, FIRST REVISION IN 2007, WERE NOT AT THIS HOSPITAL SO PAST REVISION INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221982 SCORPIO TS MOD. TIB. TRAY IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 6PDMAD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention