BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P - CE FULL DOSE 10-PK

    MDR report key: 5062380 · Received September 8, 2015

    Report

    Report Number
    0002249697-2015-02921
    Event Type
    Death
    Date Received
    September 8, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. 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

    AN EVENT REGARDING A PATIENT DEATH AFTER PROBLEMS THAT OCCURRED DURING SURGERY INVOLVING SIMPLEX P BONE CEMENT WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH MEDICAL RECORDS. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW BY A CLINICAL CONSULTANT INDICATED: FAT EMBOLISM SYNDROME DURING HEMI-ARTHROPLASTY OF THE HIP AT THE STAGE OF CEMENT APPLICATION AND STEM INSERTION CAUSED A FATAL COLLAPSE OF ALL CARDIO-RESPIRATORY FUNCTIONS FOR WHICH RESUSCITATION WAS NOT SUCCESSFUL. WITH REGARD TO PROCEDURE RELATED FACTORS, A CEMENT RESTRICTOR IN FEMORAL CANAL REPORTED PRIOR TO CEMENTATION APPEARED NOT TO HAVE BEEN USED. PATIENT RELATED FACTORS INCLUDED: HYPOVOLEMIC CONDITION AS CAUSED BY MULTIPLE FRACTURES AND DELAY BETWEEN TRAUMA AND HOSPITAL ADMISSION; SEVERE ANEMIA; HYPOKALEMIA; HYPONATREMIA AND HYPO-PROTEINEMIA INDICATING THE PATIENT WAS IN MARGINAL MEDICAL CONDITION. THE PATIENT DIED. NO DEVICE RELATED FACTORS WERE IDENTIFIED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE MEDICAL REVIEW INDICATED THAT FAT EMBOLISM SYNDROME DURING HEMI-ARTHROPLASTY OF THE HIP AT THE STAGE OF CEMENT APPLICATION AND STEM INSERTION CAUSED A FATAL COLLAPSE OF ALL CARDIO-RESPIRATORY FUNCTIONS FOR WHICH RESUSCITATION WAS NOT SUCCESSFUL. THE PATIENT DIED. THE IFU WARNS AGAINST SUCH EVENTS. NO DEVICE RELATED FACTORS WERE IDENTIFIED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    HIP REPLACEMENT. A SHARP DROP IN BLOOD PRESSURE WHEN SIMPLEX WAS INJECTED. THE PATIENT HAS DIED.

    Description of Event or Problem · 1

    HIP REPLACEMENT. A SHARP DROP IN BLOOD PRESSURE WHEN SIMPLEX WAS INJECTED. THE PATIENT HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594269 SIMPLEX P - CE FULL DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH CBU025

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death