BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P - CE ABC FD 10-PK

    MDR report key: 1822754 · Received August 30, 2010

    Report

    Report Number
    9610726-2010-00267
    Event Type
    Death
    Date Received
    August 30, 2010
    Date of Event
    October 1, 2009
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. PRODUCT WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    THE THEATRE MANAGER REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT A HIP REPLACEMENT ON THE (B)(6) 2009. THE THEATRE MANAGER REPORTED THAT THE ANTIBIOTIC SIMPLEX CEMENT WENT OFF QUICKER THAN USUAL, WHICH HE BELIEVED TO BE IN APPROXIMATELY 3.5 TO 4 MINUTES WHICH CAUSED THE STEM TO BECOME STUCK HALF WAY IN THE FEMUR. THE THEATRE MANAGER FURTHER REPORTED THAT THE STEM AND THE CEMENT WERE REMOVED AND THE PROCESS BEGAN AGAIN, CAUSING APPROXIMATELY 1 HOUR ADDITIONAL ANESTHESIA TIME. ANAESTHESIA REPORTED THAT THE THEATRE WAS AS ITS NORMAL TEMPERATURE. THE THEATRE MANAGER REPORTED THAT THE PATIENT SUFFERED A CARDIAC EVENT WHILE ON THE TABLE AND WAS GIVEN CPR AND THEY MANAGED TO "GET THE PATIENT BACK". THE THEATRE MANAGER REPORTED THAT THE PATIENT WAS UNSTABLE IN RECOVERY SO WAS TRANSFERRED TO INTENSIVE CARE WHERE SHE SUBSEQUENTLY DIED. THE REPORTER STATED THAT HE DID NOT KNOW THE PRECISE EVENTS PRIOR TO THE PATIENT'S DEATH. THE THEATRE MANAGER REPORTED THAT HE BELIEVED THE PATIENT MAY HAVE HAD A CONDUCTIVITY ISSUE WITH HER HEART DUE TO AGE ALTHOUGH THE PATIENT HAD STATED PRIOR TO THE PROCEDURE THAT SHE HAD NO KNOWN HEART CONDITION. THE THEATRE MANAGER CONFIRMED THAT THE EVENT HAD NOT BEEN REPORTED TO STRYKER AT THE TIME AND THAT TO HIS KNOWLEDGE, THE HOSPITAL HAD NOT EXPERIENCED ANY ISSUES WITH OTHER UNITS FROM THE BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE ABC FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA BGQ023

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death