BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 3362096 · Received September 23, 2013

    Report

    Report Number
    0002249697-2013-03096
    Event Type
    Death
    Date Received
    September 23, 2013
    Date of Event
    August 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K062553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE CORRECTED. AN EVENT REGARDING A CARDIAC ARREST RESULTING IN PATIENT DEATH INVOLVING SIMPLEX P BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED AS THE DEVICE REMAINS IMPLANTED IN THE PATIENT ALSO INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW. THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS OPERATIVE REPORTS, PROGRESS NOTES DETAILING SEQUENCE OF EVENTS AND CONFIRMATION OF AMOUNT OF SIMPLEX USED DURING SURGERY ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PROXIMAL FEMORAL ARTHROPLASTY USING A CEMENTED MODULAR PROXIMAL FEMORAL REPLACEMENT PROSTHESIS. DURING THE CEMENTING PROCESS. THE PATIENT BECAME HYPOSENSITIVE AND A CARDIAC ARREST OCCURRED. CPR WAS BEGAN. DURING CPR, A TEE-TRANS-ESOPHAGEAL ECHOCARDIOGRAM SHOWED LARGE AMOUNTS OF THROMBOSIS IN THE RIGHT SIDE OF THE HEART. CARDIOTHORACIC SURGERY WAS CONSULTED AND WE ELECTED TO PROCEED WITH CARDIOPULMONARY BYPASS AND OPEN HEART SURGERY TO REMOVE ALL VISIBLE CLOT IN THE HEART, PULMONARY ARTERIES AND THE INFERIOR VENA CAVA. THE PATIENT'S HIP PROCEDURE WAS THEN COMPLETED. TRANSFERRED ICU AND FAMILY ELECTED TO DISCONTINUE ALL LIFE SUPPORT. PT WAS A NO CODE PRIOR TO OPERATING ROOM,. THREE BATCHES OF STRYKER SIMPLEX CEMENT WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A PROXIMAL FEMORAL ARTHROPLASTY USING A CEMENTED MODULAR PROXIMAL FEMORAL REPLACEMENT PROSTHESIS. DURING THE CEMENTING PROCESS. THE PATIENT BECAME HYPOSENSITIVE AND A CARDIAC ARREST OCCURRED. CPR WAS BEGAN. DURING CPR, A TEE-TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED LARGE AMOUNTS OF THROMBOSIS IN THE RIGHT SIDE OF THE HEART. CARDIOTHORACIC SURGERY WAS CONSULTED AND WE ELECTED TO PROCEED WITH CARDIOPULMONARY BYPASS AND OPEN HEART SURGERY TO REMOVE ALL VISIBLE CLOT IN THE HEART, PULMONARY ARTERIES AND THE INFERIOR VENA CAVA. THE PATIENTS HIP PROCEDURE WAS THEN COMPLETED. TRANSFERRED ICU AND FAMILY ELECTED TO DISCONTINUE ALL LIFE SUPPORT. PT WAS A NO CODE PRIOR TO OPERATING ROOM,. THREE BATCHES OF STRYKER SIMPLEX CEMENT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478952 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MKT108

    Patients

    Seq Age Sex Outcome Treatment
    1 Death