BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 3336058 · Received August 28, 2013

    Report

    Report Number
    9617083-2013-00013
    Event Type
    Other
    Date Received
    August 28, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 23, 2013
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    PMA / PMN Number
    K021551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: BASED ON THE INFORMATION PROVIDED THE PATIENT'S RENAL FUNCTION WAS STATED TO BE FUNCTIONING NORMALLY; HOWEVER, IT IS POSSIBLE THAT THE PATIENT'S PREVIOUS HISTORY OF ACUTE KIDNEY INJURY AND HYPERTENSION MAY BE A CONTRIBUTORY FACTOR. STIMULAN RAPID CURE IS CONTRA INDICATED FOR RENAL COMPROMISED PATIENTS. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ANKYLOSING SPONDYLITIS, HYPERTENSION, AND AN EPISODE OF ACUTE KIDNEY INJURY SECONDARY TO SEPSIS TWO YEARS PREVIOUS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED FOR ELECTIVE REVISION OF HIS LEFT PROXIMAL FEMORAL REPLACEMENT DUE TO A PERSISTENT PERIPROSTHETIC JOINT INFECTION. THE POST-OPERATIVE PERIOD WAS COMPLICATED BY DISCHARGE FROM HIS WOUND, NECESSITATING A RETURN TO THEATRE 5 DAYS LATER FOR EXPLORATION AND WASHOUT. DURING THIS SECOND PROCEDURE, 40 CC OF STIMULAN RAPID CURE LOADED WITH FOUR GRAMS OF VANCOMYCIN WAS MIXED BY SURGEONS EXPERIENCED IN THEIR USE, AND IMPLANTED AROUND THE PROSTHESIS AND SURROUNDING SOFT TISSUE. FORTY EIGHT HOURS POST-OPERATIVELY THE PATIENT BECAME CONFUSED AND LETHARGIC. VENOUS BLOOD SAMPLES REVEALED RAISED SERUM CALCIUM OF 3.17 MMOL/L, WITH NORMAL RENAL, PARATHYROID AND ENDOCRINE FUNCTION. SERUM CALCIUM CONTINUED TO RISE TO 3.54 MMOL/L OVER THE SUBSEQUENT 48 HR TREATMENT WITH I.V. FLUIDS WAS COMMENCED. HIS SYMPTOMS ABATED, AND AS A PRECAUTION THE PATIENT WAS MOVED TO INTENSIVE CARE FOR OBSERVATION. HOWEVER, AS HIS SERUM MARKERS CONTINUED TO IMPROVE ON I.V. FLUID THERAPY, THE PATIENT REMAINED ASYMPTOMATIC AND WAS DISCHARGED HOME WITH NORMAL SERUM CALCIUM OF 2.46 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423618 STIMULAN RAPID CURE STIMULAN RAPID CURE MQV BIOCOMPOSITES LTD. 05/13-R177

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention