BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 2465249 · Received February 21, 2012

    Report

    Report Number
    9612392-2012-00001
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    December 29, 2011
    Report Date
    January 24, 2012
    Manufacturer
    SEIKAGAKU CORP
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DEFINITIVE REPORT. OUR MEDICAL ADVISER'S COMMENT: FROM THE TEST RESULTS THAT SHOW NEU 95%, MONO/MACRO 5%, LYMP, EOS AND BASO 0% IN THE JOINT FLUID, ALLERGIC REACTION AND FOREIGN BODY REACTION CAN BE RULED OUT AS THE CAUSE OF THIS CASE. THIS CASE DOES NOT FIT COMPLETELY INTO THE DEFINITION OF PSEUDOSEPTIC REACTION REPORTED BY GOLDBERG VM IN CLIN ORTHOP 2004; 419; 130 - 137. INFECTION IS RULE OUT BASED ON THE CULTURE RESULTS NEGATIVE INCLUDING CRP < 0.10 MM/H, SED RATE 6 MM/H. IN CONCLUSION, IT IS THOUGH THAT LOCAL SWELLING AND PAIN DESCRIBED IN THE PACKAGE INSERT OCCURRED IN THIS CASE, BUT THE CAUSE IS UNIDENTIFIED.

    Description of Event or Problem · 1

    ADVERSE EVENT: PSEUDOSEPTIC REACTION: ON (B)(6) 2011 - AN (B)(6) FEMALE PT RECEIVED FIRST INJECTION OF SUPARTZ IN THE RIGHT KNEE FOR OSTEOARTHRITIS AND TOLERATED WELL. ON (B)(6) 2011 - SHE RECEIVED SECOND INJECTION OF SUPARTZ IN THE RIGHT KNEE AND TOLERATED WELL. ON (B)(6) 2011 - SHE RECEIVED THIRD INJECTION OF SUPARTZ IN THE RIGHT KNEE AND TOLERATED WELL. ON (B)(6) 2011 - SHE RECEIVED FOURTH INJECTION OF SUPARTZ IN THE RIGHT KNEE AND TOLERATED WELL. APPROX 2 HOURS AFTER RECEIVING HER FOURTH INJECTION, SHE DEVELOPED SEVERE PAIN AND SWELLING AT THE KNEE JOINT. SHE CONTACTED THE INJECTION PHYSICIAN AND REPORTED PAIN AND SWELLING, AND INABILITY TO BEND HER KNEE. SHE WAS ADVISED BY THE INJECTION PHYSICIAN TO TAKE TYLENOL AND ICE PACKS. ON (B)(6) 2012 - SHE WAS EVALUATED BY THE INJECTION PHYSICIAN. SHE HAD SEVERE SWELLING AND WAS EXPERIENCING PAIN. THE PHYSICIAN EXAMINED HER, USED ULTRASOUND TO CONFIRM THE EFFUSION AND SUBSEQUENTLY ASPIRATED THE EFFUSION FOR ANALYSES AND CULTURE. THE PHYSICIAN STATED THAT SHE WAS AFEBRILE. THE JOINT FLUID WAS NOT PURULENT. THE JOINT FLUID ANALYSIS RESULTS INDICATED THERE WERE NO CRYSTALS PRESENT AND NO INDICATIONS OF INFECTION; HOWEVER, THERE WERE SIGNS OF INFLAMMATION. IT WAS NOTED THAT WITH EACH INJECTION ADMINISTERED TO THE PT, ULTRASOUND WAS USED. THEREFORE, THERE IS EVIDENCE THAT SWELLING WAS NOT PRESENT IN THE KNEE JOINT PRIOR TO THE FOURTH INJECTION. IN ADDITION, THE INJECTION PHYSICIAN STATED, SHE IS CERTAIN THE PLACEMENT OF THE INJECTION WAS CORRECT AND IN THE KNEE JOINT. SHE DECLINED USE OF NARCOTICS; THEREFORE, SHE CONTINUED REGIMEN OF ICE PACKS AND MOTRIN/TYLENOL. ON (B)(6) 2012 - SHE WAS EVALUATED BY THE INJECTION PHYSICIAN. THE KNEE WAS STILL SWOLLEN AND SHE WAS EXPERIENCING SEVERE PAIN. THE KNEE WAS ASPIRATED AGAIN. THE RESULTS INDICATED NO CRYSTALS, NO INFECTION, BUT INDICATED INFLAMMATION. THE PHYSICIAN DID NOT TREAT HER WITH ANTIBIOTICS BECAUSE SHE FELT THAT BASED ON HER CLINICAL EXAM, LAB AND JOINT FLUID FINDINGS THAT SHE HAD NO EVIDENCE OF INFECTION. ON (B)(6) 2012 - SHE WAS EVALUATED BY THE INJECTION PHYSICIAN. SHE STILL HAD THE SAME SYMPTOMS. HER RECOVERY WAS SLOW IN PROGRESS. SHE WAS ADMINISTERED AN INJECTION OF CORTISONE FOR PAIN AND SWELLING. ON (B)(6) 2012 - SINCE THE CORTICOSTEROID INJECTION, SHE HAS IMPROVED ABOUT 40% AND IS BEING FOLLOWED QUITE CLOSELY. ON (B)(6) 2012 - SHE WAS FEELING ABOUT 50% IMPROVED. THE PHYSICIAN STATED THAT SHE ADMINISTERS 20 INJECTIONS DAILY AT HER FACILITY. THIS IS THE FIRST INCIDENT SHE HAS SEEN THE REPORTED SYMPTOMS. THE INJECTION PHYSICIAN STATES HER CAUSAL OPINION IS PSEUDOSEPTIC REACTION RELATED TO SUPARTZ. THE REASON FOR HER DIAGNOSIS IS THAT ALL INJECTIONS WERE ADMINISTERED UNDER ULTRASOUND, AND THERE WAS NO EDEMA PRESENT PRIOR TO THE INJECTIONS. THE PHYSICIAN WANTED TO REPORT THE INCIDENT BECAUSE SHE FEELS THAT PSEUDOSEPTIC REACTION IS UNDER REPORTED FOR HYALURONIC ACID INJECTIONS. THE PHYSICIAN IS CONVINCED THAT THE PT EXPERIENCED A PSEUDOSEPTIC REACTION SINCE OTHER CAUSES OF THE REACTION HAVE BEEN RULED OUT. SHE IS ABSOLUTE CERTAIN THE INJECTION WAS ADMINISTERED CORRECTLY AND IS DEFINITIVE WITH HER DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other