BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 3002694 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00974
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. VISUAL INSPECTION AND FUNCTIONAL TESTING WAS COMPLETED ON THE THREE RETAIN SAMPLES OF THIS LOT. THE RESULTS WERE SATISFACTORY AND WITHIN SPECIFICATION. THE MIXING CHARACTERISTICS AND WORKING PROPERTIES OF SURGICAL SIMPLEX BONE CEMENTS ARE INFLUENCED PRIMARILY BY THE TEMPERATURE OF THE LIQUID AND POWDER COMPONENTS AT THE TIME OF MIXING AND BY THE TEMPERATURES OF THE UTENSILS WITH WHICH IT CONTACTS DURING MIXING E.G. MIXING BOWLS, CEMENT INTRODUCERS ETC. GENERALLY, HIGHER TEMPERATURES ACCELERATE THE POLYMERISATION REACTION AND LOWER TEMPERATURES DELAY IT. OTHER FACTORS WHICH CAN AFFECT SETTING TIME ARE MIXING TECHNIQUE (SPEED, USE OF VACUUM, CENTRIFUGATION), THOROUGHNESS OF MIXING, COMPLETE UTILIZATION OF ALL OF THE POWDER & LIQUID AND CARE TO AVOID INCLUSION OF ANY EXTRANEOUS MATERIAL SUCH AS BLOOD OR STERILISATION SOLUTIONS INTO THE MIX. MIXING PROCESS/TECHNIQUE ISSUES ARE HIGHLIGHTED IN THE OR HANDBOOK. THE MIXING PROPERTIES OF THE RETAIN SAMPLES OF THE REPORTED LOT CODE TJT056 WERE TESTED AND SHOW THAT ALL REQUIRED SPECIFICATIONS ARE MET. IT WAS NOT POSSIBLE TO REPLICATE THIS EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT HARDENED PREMATURELY (WITHIN 6 MINUTES) WHILE PLACING THE IMPLANT STEM OF THE HIP REPLACEMENT BEFORE THE STEM WAS COMPLETELY DOWN THE FEMUR SHAFT. AS A RESULT THE HIP REPAIR BECAME A REVISION CAUSING A HIP FRACTURE AND SURGICAL DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT HARDENED PREMATURELY (WITHIN 6 MINUTES) WHILE PLACING THE IMPLANT STEM OF THE HIP REPLACEMENT BEFORE THE STEM WAS COMPLETELY DOWN THE FEMUR SHAFT. AS A RESULT THE HIP REPAIR BECAME A REVISION CAUSING A HIP FRACTURE AND SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105463 SIMPLEX TOBRAMYCIN 1 PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH TJT056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other