BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125

    MDR report key: 3895077 · Received June 25, 2014

    Report

    Report Number
    0002249697-2014-02429
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K040734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN 6276-1- CONE BODY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INFECTION INVOLVING A RESTORATION MODULAR BODY WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION INDICATED THE STEM SHOWED SIGNS OF INGROWTH AND IN VIVO USE. DEVICE HISTORY REVIEW: RECORDS INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED STERILE LOT OR LOT IDS. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    EXPLANTATION OF A RESTORATION MODULAR: CONE CONICAL AFTER INFECTION. INGROWTH OF THE IMPLANT HAD TAKEN PLACE, SO IT WAS NOT POSSIBLE TO DISCONNECT THE BODY FROM THE STEM WITHOUT PREPARING THE IMPLANT SITE. THE INTENTION WAS TO DISCONNECT THE BODY FROM THE STEM WHEN THE SITE OF THE WAS FULLY PREPARED AND THEN USE AN OPEN DRILL TO REMOVE THE STEM. BUT UNFORTUNATELY IT WAS NOT POSSIBLE TO DISCONNECT THE BODY FROM THE STEM, ALTHOUGH THE BODY WAS FULLY EXPOSED AND NOT CONNECTED TO BONE ANYMORE. THE INSTRUMENTS WERE USED PROPERLY AND SEVERAL ATTEMPTS WERE MADE. BECAUSE THEY WERE NOT ABLE TO DISCONNECT THE BODY FROM THE STEM, THEY COULD NOT DRILL THE STEM OUT SO THEY HAD TO OPEN THE FEMUR. IT WAS A 195MM STEM, SO A LARGE PART OF THE FEMUR HAD TO BE OPENED. EVENTUALLY THEY REMOVED THE STEM AND REPLACED A NEW CONE CONICAL WITH DALL MILES CABLES.

    Description of Event or Problem · 1

    EXPLANTATION OF A RESTORATION MODULAR: CONE CONICAL AFTER INFECTION. INGROWTH OF THE IMPLANT HAD TAKEN PLACE, SO IT WAS NOT POSSIBLE TO DISCONNECT THE BODY FROM THE STEM WITHOUT PREPARING THE IMPLANT SITE. THE INTENTION WAS TO DISCONNECT THE BODY FROM THE STEM WHEN THE SITE OF THE WAS FULLY PREPARED AND THEN USE AN OPEN DRILL TO REMOVE THE STEM. BUT UNFORTUNATELY IT WAS NOT POSSIBLE TO DISCONNECT THE BODY FROM THE STEM, ALTHOUGH THE BODY WAS FULLY EXPOSED AND NOT CONNECTED TO BONE ANYMORE. THE INSTRUMENTS WERE USED PROPERLY AND SEVERAL ATTEMPTS WERE MADE. BECAUSE THEY WERE NOT ABLE TO DISCONNECT THE BODY FROM THE STEM, THEY COULD NOT DRILL THE STEM OUT, SO THEY HAD TO OPEN THE FEMUR. IT WAS A 195MM STEM, SO A LARGE PART OF THE FEMUR HAD TO BE OPENED. EVENTUALLY THEY REMOVED THE STEM AND REPLACED A NEW CONE CONICAL WITH DALL MILES CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371202 25MM MOD REV HIP BDY/BLT +10MMCOMPONENT LEVEL 9006-1-125 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 36779802

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R