BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 2046978 · Received March 31, 2011

    Report

    Report Number
    9610726-2011-00094
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 16, 2011
    Manufacturer
    STRYKER ORTHPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD NO ALLERGIES TO ANY ANTIBIOTIC. TOBRA WAS USED FOR THE SURGERY. PATIENT PRESENTED WITH RASH. DISCUSSION BETWEEN SURGEONS THE PATIENT WAS KNOWN TO HAVE INFLAMMATORY SYNOVITIS, AND AS PER ROUTINE, SURGEON USED PERIOPERATIVE VANCOMYCIN TO COVER THE SURGERY. SURGEON ALSO USED SIMPLEX P WITH TOBRA. IT WAS FURTHER DISCUSSED THE FDA APPROVED LABELING AND SURGEON IS AWARE THAT THIS WAS OUTSIDE THE CURRENT FDA APPROVED INDICATION. THE PATIENT WAS DISCHARGED FROM HOSPITAL ROUTINELY, BUT ONE WEEK POST SURGERY DEVELOPED AN ALL OVER BODY RASH. PATIENT CONSULTED AN ALLERGIST WHO SUGGESTED REVIEW BY SURGICAL TEAM. SURGEON WONDERS WHETHER THIS REPRESENTS AN ALLERGY / SENSITIVITY TO TOBRAMYCIN. THE RASH RESOLVED SPONTANEOUSLY WITH NO ADDITIONAL MEDICAL INTERVENTION AFTER ONE WEEK (TWO WEEKS POST SURGERY). AS YET SURGEON'S DETERMINATION IS THAT THIS IS NOT A SERIOUS ADVERSE EVENT, AND THAT RELATIONSHIP TO THE SIMPLEX P WITH TOBRA IS POSSIBLE, BUT NOT CERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other