BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 3931375 · Received April 9, 2014

    Report

    Report Number
    9617083-2014-00010
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    PMA / PMN Number
    K021551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMORBIDITIES DETAILS PROVIDED: AGE, PREVIOUS LEFT KNEE INFECTION WITH STAPH AUREUS, CURRENT LEFT KNEE INFECTION WITH (B)(6), HTN, CAD, ANEMIA. SURGERY DETAILS: 1.2 POWDERED TOBRAMYCIN AND 1G VANCOMYCIN HAD BEEN USED PER 10CC STIMULAN RAPID CURE - 50CC WAS USED. 'VANCOMYCIN BEADS' PLACED PERIOPERATIVELY, THE PATIENT WAS PLACED ON VANCOMYCIN IV POST OP, AND DEVELOPED VANCO TOXICITY ON POD3 WITH ASSOCIATED RENAL FAILURE, AND HYPERCALCEMIA ON POD3 ALSO. CALCIUM LEVELS AS HIGH AS 15.3 POD27 (DESPITE HEMODIALYSIS) THEN STARTED TO DROP, NORMAL LEVELS ON POD30. STATUS AS AT (B)(6) 2014: PATIENT IS DOING WELL, THOUGH WEAK PHYSICALLY, ON SUPPLEMENTAL02, WILL NEED PHYSICAL REHABILITATION, ELECTROLYTES ARE NORMAL, OFF IV THERAPY, OFF HEMODIALYSIS, WILL BE PLACED ON ORAL ANTIBIOTICS UPON D/C TO REHAB. SUSPECTED ROOT CAUSE: A LARGE AMOUNT OF ANTIBIOTICS HAVE BEEN USED, LOCALLY AND IV - VANCOMYCIN TOXICITY HAD DEVELOPED AND ASSOCIATED RENAL FAILURE, WHICH MAY HAVE CONTRIBUTED TO HYPERCALCEMIA. HYPERCALCEMIA AND RENAL COMPROMISED PATIENTS ARE CONTRAINDICATED. ADDITIONAL LOT#: 09/13R194. ADDITIONAL DEVICE MANUFACTURE DATE: 09/01/2013.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PROCEDURE UNDERTAKEN ON 18/02/2014 WAS I AND D WITH POLY EXCHANGE FOR EARLY INFECTION IN A MULTIPLY OPERATED PATIENT WITH A DISTAL FEMORAL REPLACEMENT. APPROXIMATELY 3 WEEKS AFTER RECEIVING 50 CC STIMULAN RAPID CURE, THE PATIENT HAD UNEXPLAINED HYPERCALCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212940 STIMULAN RAPID CURE BONE VOID FILLER/GRAFT EXTENDER MQV BIOCOMPOSITES LTD. 08/13R192

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization