BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG PS FEMORAL #4 RIGHT

    MDR report key: 4210953 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04044
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    April 10, 2013
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K030978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER SCORPIO RIGHT KNEE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE 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. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A METAL ALLERGIC REACTION AND LOOSENING INVOLVING A SCORPIO NRG PS FEMORAL #4 RIGHT WAS REPORTED. THE METAL ALLERGY WAS CONFIRMED THROUGH MEDICAL RECORDS, WHILE THE LOOSENING WAS NOT CONFIRMED. METHOD & RESULTS: A VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS WERE REVIEWED BY A CLINICAL CONSULTANT AND REVEALED: ¿BLOOD TESTING DATA SHOWS A HOST OF SENSITIVITIES AND REACTIVITIES..... THERE IS NOTHING UNIQUE ABOUT THE ALLOYS USED IN THE SCORPIO NRG SYSTEM COMPARED TO COMPETITIVE PRODUCTS, WHICH WOULD ALTER THE LIKELIHOOD OF ALLERGIC REACTIONS IN A PATIENT WITHOUT A PRIOR HISTORY OF TESTING FOR METAL ALLERGIES PRIOR TO SURGERY.¿ THERE IS NO MENTION OF LOOSE COMPONENTS. THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS MANUFACTURING LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE PATIENT¿S ALLERGIC REACTION WAS DUE TO METAL SENSITIVITY. THE CAUSE OF THE REPORTED LOOSENING COULD NOT BE DETERMINED AS THERE IS NO COMPONENT LOOSENING INDICATED OR MENTIONED IN THE PROVIDED MEDICAL RECORDS. TO THE CONTRARY THE OPERATIVE REPORT DOES STATE THAT AN OSCILLATING SAW AND FLEXIBLE OSTEOTOMES WERE REQUIRED TO REMOVE THE COMPONENTS AS WELL AS A SLAP HAMMER TO REMOVE THE FEMORAL COMPONENT. TO CONFIRM THE LOOSENING AND ITS CAUSE, FURTHER MEDICAL RECORDS AND THE RETURN OF THE DEVICES ARE NEEDED. IT WAS ALSO CONCLUDED THAT THERE IS NO INDICATION THE EVENT IS RELATED TO A MANUFACTURING ISSUE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD RIGHT KNEE SURGERY ON (B)(6) 2013. ONE WEEK AFTER SHE RETURNED FROM THERAPY, SHE HAD A REACTION THROUGHOUT HER BODY AND HAD TO BE LIFTED OUT OF BED. PATIENT STATED SHE WANTED TO BE TESTED FOR METAL REACTION PRIOR TO PRIMARY SURGERY, BUT DOCTOR WOULD NOT HAVE HER TESTED. SHE HAD PAIN AND LOOSENING. PATIENT UNDERWENT A REVISION ON (B)(6) 2014. SHE STATED AS SOON AS METAL WAS TAKEN OUT OF HER BODY SHE HAS NO PAIN AND CAN DO EVERYTHING SHE COULD NOT HAVE DONE PRIOR TO THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD RIGHT KNEE SURGERY ON (B)(6), 2013. ONE WEEK AFTER SHE RETURNED FROM THERAPY, SHE HAD A REACTION THROUGHOUT HER BODY AND HAD TO BE LIFTED OUT OF BED. PATIENT STATED SHE WANTED TO BE TESTED FOR METAL REACTION PRIOR TO PRIMARY SURGERY, BUT DOCTOR WOULD NOT HAVE HER TESTED. SHE HAD PAIN AND LOOSENING. PATIENT UNDERWENT A REVISION ON (B)(6) 2014. SHE STATED AS SOON AS METAL WAS TAKEN OUT OF HER BODY SHE HAS NO PAIN AND CAN DO EVERYTHING SHE COULD NOT HAVE DONE PRIOR TO THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD RIGHT KNEE SURGERY ON (B)(6) 2013. ONE WEEK AFTER SHE RETURNED FROM THERAPY, SHE HAD A REACTION THROUGHOUT HER BODY AND HAD TO BE LIFTED OUT OF BED. PATIENT STATED SHE WANTED TO BE TESTED FOR METAL REACTION PRIOR TO PRIMARY SURGERY, BUT DOCTOR WOULD NOT HAVE HER TESTED. SHE HAD PAIN AND LOOSENING. PATIENT UNDERWENT A REVISION ON (B)(6) 2014. SHE STATED AS SOON AS METAL WAS TAKEN OUT OF HER BODY SHE HAS NO PAIN AND CAN DO EVERYTHING SHE COULD NOT HAVE DONE PRIOR TO THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692309 SCORPIO NRG PS FEMORAL #4 RIGHT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLRNX2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention