BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 132 HIP STEM #7

    MDR report key: 5894266 · Received August 22, 2016

    Report

    Report Number
    0002249697-2016-02680
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    September 24, 2015
    Report Date
    July 25, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 06-2600, C-TAPER COCR LFIT HEAD 26MM/0, LOT CODE: MNPKP6; CAT. NO.: UH1-46-26. UHR BIPOLAR 26X46MM, LOT CODE: MLPJ63. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 10 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 17-NOV-2014 WITH NO REPORTED DISCREPANCIES. REVIEW OF THE COMPLAINT HISTORY SHOWED THAT THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015 AFTER AN OPERATION, PATIENT CANNOT GET OUT HER BED AND LEFT UPPER LIMBS WEAKNESS. ON (B)(6) 2015 PATIENT UNABLE TO CHANGE POSITION IN BED AND LEAVE HER BED. RASH APPEARS ON LEGS AND UPPER LIMBS FROM TIME TO TIME. IN (B)(6) 2016, 85% OF THE BASE OF PATIENT'S BRAIN NECROSIS. THE PATIENT HAS A DISABILITY CARD NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546594 SECUR-FIT MAX 132 HIP STEM #7 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH MNNVAV

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other