BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P WITH TOBRAMYCIN 1 PACK

    MDR report key: 4621145 · Received March 20, 2015

    Report

    Report Number
    0002249697-2015-00801
    Event Type
    Death
    Date Received
    March 20, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 23, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A CARDIAC ARREST RESULTING IN PATIENT DEATH INVOLVING SIMPLEX P BONE CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PATIENT HISTORY, OPERATIVE REPORTS AND MEDICAL NOTES DETAILING THE 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 AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING REVISED FOR THE SECOND STAGE OF THE REVISION ON THE LEFT HIP FROM A COMPETITOR ANTIBIOTIC SPACER. THE TRIALING WAS PERFORMED WITH NO ISSUE. THE PATIENTS CANAL WAS PREPARED WITH CEMENT. THE PATIENT CODED. THE SURGEON QUICKLY CLOSED THE PATIENT WITH THE HEAD TRIAL IMPLANTED TO PLACE THE PATIENT ON THEIR BACK TO PERFORM CPR. THE PATIENT WAS NOT REVIVED AND DIED ON THE TABLE. THE HEAD TRIAL REMAINS IMPLANTED IN THE PATIENT. 02-27-2015: THE SALES REP CONFIRMED THAT THE CEMENT USED WAS SIMPLEX TOBRA. THE PATIENT'S PRIMARY HIP WAS SMITH AND NEPHEW. SHE HAD BEEN REVISED FOR INFECTION AND HAD BIOMET SPACER'S IMPLANTED. THE REPORTED EVENT OCCURRED DURING THE REMOVAL OF THE SPACERS.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING REVISED FOR THE SECOND STAGE OF THE REVISION ON THE LEFT HIP FROM A COMPETITOR ANTIBIOTIC SPACER. THE TRIALING WAS PERFORMED WITH NO ISSUE. THE PATIENTS CANAL WAS PREPARED WITH CEMENT. THE PATIENT CODED. THE SURGEON QUICKLY CLOSED THE PATIENT WITH THE HEAD TRIAL IMPLANTED TO PLACE THE PATIENT ON THEIR BACK TO PERFORM CPR. THE PATIENT WAS NOT REVIVED AND DIED ON THE TABLE. THE HEAD TRIAL REMAINS IMPLANTED IN THE PATIENT. (B)(6) 2015: THE SALES REP CONFIRMED THAT THE CEMENT USED WAS SIMPLEX TOBRA. THE PATIENT'S PRIMARY HIP WAS SMITH AND NEPHEW. SHE HAD BEEN REVISED FOR INFECTION AND HAD BIOMET SPACER'S IMPLANTED. THE REPORTED EVENT OCCURRED DURING THE REMOVAL OF THE SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190107 SIMPLEX P WITH TOBRAMYCIN 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MGV056

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death