BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIOFLEX PS TIB INSERT

    MDR report key: 4221735 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04135
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    February 11, 2005
    Report Date
    October 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ADDED TO THIS REPORT: SCORPIO PS FEMUR WAFFLE POSTS W/LFIT, CAT# 71-4509R, LOT# K04V886. SERIES 7000 STANDARD TIBIA, CAT# 7115-0009, LOT# T04W1290. SCORPIO U-DOME PATELLA, CAT# 73-3508, LOT# S401. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVENT REGARDING LOOSENING INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE ITEM WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: "THERE IS NO EVIDENCE THAT THE NONSPECIFIC SYMPTOMS REFERABLE TO THE RIGHT TOTAL KNEE ARTHROPLASTY ARE RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING, OR MATERIALS." DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED FOR EVALUATION. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND/OR X-RAYS BY A CLINICAL CONSULTANT INDICATED: "ON (B)(6) 2015 MULTIPLE IMAGES OF A THREE-PHASE BONE SCAN OF BOTH LOWER EXTREMITIES DEMONSTRATES NO EVIDENCE OF LOOSENING OR PATHOLOGY IN THE RIGHT TOTAL KNEE ARTHROPLASTY. THERE IS NO EVIDENCE THAT THE NONSPECIFIC SYMPTOMS REFERABLE TO THE RIGHT TOTAL KNEE ARTHROPLASTY ARE RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING, OR MATERIALS. A RIGHT LOWER EXTREMITY BURN, RIGHT LUMBAR LOWER EXTREMITY RADICULOPATHY AND PERSISTENT SMOKING AND ALCOHOL ABUSE WITH A HEMARTHROSIS OF THE RIGHT KNEE IN (B)(6) 2014 MAY RELATE TO TRAUMA AND LIFESTYLE." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REPORTED, IN 2009 AND (B)(6) 2014 DOCTOR HAD TO DRAIN FLUID FROM HIS KNEE. HE IS EXPERIENCING LOTS OF PAIN, HAS SWELLING IN KNEE AREA HEARS CLICKING NOISE, AND HAS TO WEAR A BRACE TO STABILIZE HIS KNEE. HE SAID WITHOUT THE BRACE THE KNEE COMES OUT OF PLACE. REVISION SURGERY IS PENDING. UPDATE: PER EMAIL PATIENT REPORTED "LOOSENING OF IMPLANT."

    Description of Event or Problem · 1

    PATIENT REPORTED, IN 2009 AND (B)(6) 2014 DOCTOR HAD TO DRAIN FLUID FROM HIS KNEE. HE IS EXPERIENCING LOTS OF PAIN, HAS SWELLING IN KNEE AREA HEARS CLICKING NOISE, AND HAS TO WEAR A BRACE TO STABILIZE HIS KNEE. HE SAID WITHOUT THE BRACE THE KNEE COMES OUT OF PLACE. REVISION SURGERY IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703286 SCORPIOFLEX PS TIB INSERT KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS MBH STRYKER ORTHOPAEDICS-MAHWAH 12015501

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other