BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 5493572 · Received March 10, 2016

    Report

    Report Number
    0002249697-2016-00750
    Event Type
    Death
    Date Received
    March 10, 2016
    Date of Event
    January 28, 2016
    Report Date
    February 16, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PATIENT'S DROP IN BLOOD PRESSURE AND SUBSEQUENT DEATH DURING SURGERY INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO PRODUCT WAS RETURNED AS IT REMAINS IMPLANTED IN THE PATIENT. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: BMR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS OPERATIVE REPORT, FULL PATIENT HISTORY AS WELL AS FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    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 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.

    Description of Event or Problem · 1

    LEFT THE BASAL PARTS OF THE FEMORAL NECK FRACTURE, THE PATIENT DID SURGERY OF ARTIFICIAL FEMORAL HEAD REPLACEMENT IN (B)(6) 2016. THE SIMPLEX P WAS INSERTED FROM MEDULLARY CAVITY. THE PATIENT HAPPENED DROP IN BLOOD PRESSURE, SLOW HEARTBEAT, OXYGEN DESATURATION IN ONE TWENTY-SIX P.M. THE DOCTOR THINKS THIS STATUS MAYBE THE SIMPLEX P ADVERSE REACTIONS. THE DRUGS OF ATROPINE/ EPHEDRINE/ DEXAMETHASONE/ ADRENALINE ETC. WERE USED TO PATIENT. THE PATIENT OF HEART STOPS BEATING IN ONE FIFTY-TWO P.M. THE DOCTOR GIVEN CHEST COMPRESSIONS. THE DOCTOR PERFORMED TREATMENT AND GIVEN CHEST COMPRESSIONS/ ADRENALINE/ NOREPINEPHRINE/ DOPAMINE/ SODIUM BICARBONATE TO PATIENT .THE PATIENT WAS DEATH IN THREE FORTY P.M.

    Description of Event or Problem · 1

    LEFT THE BASAL PARTS OF THE FEMORAL NECK FRACTURE, THE PATIENT DID SURGERY OF ARTIFICIAL FEMORAL HEAD REPLACEMENT IN (B)(6) 2016. THE SIMPLEX P WAS INSERTED FROM MEDULLARY CAVITY. THE PATIENT HAPPENED DROP IN BLOOD PRESSURE, SLOW HEARTBEAT, OXYGEN DESATURATION IN ONE TWENTY-SIX P.M. THE DOCTOR THINKS THIS STATUS MAYBE THE SIMPLEX P ADVERSE REACTIONS. THE DRUGS OF ATROPINE/ EPHEDRINE/ DEXAMETHASONE/ ADRENALINE ETC. WERE USED TO PATIENT. THE PATIENT OF HEART STOPS BEATING IN ONE FIFTY-TWO P.M. THE DOCTOR GIVEN CHEST COMPRESSIONS. THE DOCTOR PERFORMED TREATMENT AND GIVEN CHEST COMPRESSIONS/ ADRENALINE/ NOREPINEPHRINE/ DOPAMINE/ SODIUM BICARBONATE TO PATIENT .THE PATIENT WAS DEATH IN THREE FORTY P.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149639 SURGICAL SIMPLEX CEMENT BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH CEU065

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death