BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL-ONE

    MDR report key: 7215013 · Received January 24, 2018

    Report

    Report Number
    9612392-2018-00002
    Event Type
    Injury
    Date Received
    January 24, 2018
    Report Date
    December 28, 2017
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    UDI-DI
    H131001111001001
    PMA / PMN Number
    P080020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS RECEIVED BY ZIMMER BIOMET ON DECEMBER 28, 2017 FROM THE INJECTION PHYSICIAN AND THE PATIENT'S WIFE. MANUFACTURER ASSURED THAT THERE WAS NO QUALITY PROBLEM BASED ON THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING AND THE ENVIRONMENTAL MONITORING FOR LOT NO. 0017E21G. AND FURTHERMORE, STERILITY TESTING WAS CONDUCTED ON JANUARY 2018 AND REVEALED NO PROBLEM. OUR MEDICAL ADVISOR'S COMMENT IS AS FOLLOWS: THIS EVENT IS THE MOST SUSPICIOUS OF SEPTIC ARTHRITIS BASED ON HIGH WBC COUNT IN FLUID ON (B)(6) (>31000), THICK APPEARANCE OF FLUID ON (B)(6), POLYS 75% IN FLUID ON (B)(6). E2011015.

    Additional Manufacturer Narrative · 0

    THE UPDATED INFORMATION WAS RECEIVED BY ZIMMER BIOMET ON APRIL 4, 2018 FROM THE PATIENT'S WIFE. THE PATIENT'S OUTCOME SEEMS TO BE STILL UNRECOVERED. MANUFACTURER ASSURED THAT THERE WAS NO QUALITY PROBLEM BASED ON THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING AND THE ENVIRONMENTAL MONITORING FOR LOT NO. 0017G21G, NOT 0017E21G. AND FURTHERMORE, STERILITY TESTING WAS CONDUCTED ON JANUARY 2018 AND REVEALED NO PROBLEM. OUR MEDICAL ADVISOR'S COMMENT IS AS FOLLOWS: THIS EVENT IS THE MOST SUSPICIOUS OF SEPTIC ARTHRITIS BASED ON 1) HIGH WBC COUNT IN FLUID ON DECEMBER 19 AND 21 (>31000), 2) THICK APPEARANCE OF FLUID ON DECEMBER 19 AND 21, 3) POLYS 75% IN FLUID ON DECEMBER 19. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF ZIMMER, INC. AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2011015.

    Description of Event or Problem · 0

    ON (B)(6) 2017 - A (B)(6) YEAR-OLD MALE PATIENT RECEIVED GEL-ONE INTO THE LEFT KNEE FOR OA. HE HAD SUCCESSFUL INJECTIONS WITH SYNVISC AND ORTHOVISC. HE ALSO HAD A STEM CELL INJECTION. HIS ONLY ALLERGY WAS IODINE. A COUPLE OF DAYS AFTER INJECTION HE BEGAN HAVING A LITTLE BIT OF PAIN. SUBSEQUENTLY HIS LEFT KNEE SWELLED UP AND HE HAD DIFFICULTY BEARING WEIGHT. ON (B)(6) 2017 - FORTY CC OF THICK BRIGHT YELLOW FLUID WAS ASPIRATED. HE WAS DIAGNOSED WITH ADVERSE REACTION DUE TO GEL-ONE. HE DID PRETTY WELL FOR 12-24 HOURS AND THEN THE FLUID REACCUMULATED. ON (B)(6) 2017 - FORTY CC OF YELLOW/BROWN THICK FLUID WAS ASPIRATED. HE RECEIVED A STEROID INJECTION. HE DID WELL FOR A COUPLE DAYS THEN THE FLUID RECURRED. BOTH SPECIMENS OF SYNOVIAL FLUID SHOWED 31,000 WBCS, NO ORGANISMS AND NO GROWTH ON CULTURE. THE INJECTION PHYSICIAN'S COLLEAGUE WHO HAVE EXPERIENCED THE SAME REACTION WITH OTHER HYALURONIC ACID PREPARATIONS BUT NOT GEL-ONE STATED THAT THE PSEUDO-INFECTION REACTION WAS ALWAYS SUCCESSFULLY TREATED WITH A SINGLE ASPIRATION. THE INJECTION PHYSICIAN DISCUSSED WITH AN INFECTIOUS DISEASE DOCTOR AND DECIDED THAT THE BEST COURSE OF TREATMENT WOULD BE TO WASH THE PATIENT'S KNEE OUT ARTHROSCOPICALLY AND GIVE A DOSE OF ROCEPHIN FOLLOWED ORAL ANTIBIOTICS. EVEN IF IT WAS NOT INFECTION THAT SHOULD CLEAN OUT ANY IRRITANTS IN THE JOINT. ON (B)(6) 2017 - EXAMINATION REVEALED A SWOLLEN TENDER LEFT KNEE. THE PATIENT COULD NOT EXTEND THE KNEE SECONDARY TO DISCOMFORT. ON (B)(6) 2018 - THE PATIENT WAS SOMEWHAT BETTER GIVEN THE CURRENT CIRCUMSTANCES. HE RECEIVED PHYSICAL THERAPY CURRENTLY AFTER UNDERWENT A SYNOVECTOMY PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A 37 YEAR-OLD MALE PATIENT RECEIVED GEL-ONE INTO THE LEFT KNEE FOR OA. HE HAD SUCCESSFUL INJECTIONS WITH SYNVISC AND ORTHOVISC. HE ALSO HAD A STEM CELL INJECTION. HIS ONLY ALLERGY WAS IODINE. A COUPLE OF DAYS AFTER INJECTION HE BEGAN HAVING A LITTLE BIT OF PAIN. SUBSEQUENTLY HIS LEFT KNEE SWELLED UP AND HE HAD DIFFICULTY BEARING WEIGHT. ON (B)(6) 2017 FORTY CC OF THICK BRIGHT YELLOW FLUID WAS ASPIRATED. HE WAS DIAGNOSED WITH ADVERSE REACTION DUE TO GEL-ONE. HE DID PRETTY WELL FOR 12-24 HOURS AND THEN THE FLUID REACCUMULATED. ON (B)(6) 2017 FORTY CC OF YELLOW/BROWN THICK FLUID WAS ASPIRATED. HE RECEIVED A STEROID INJECTION. HE DID WELL FOR A COUPLE DAYS THEN THE FLUID RECURRED. BOTH SPECIMENS OF SYNOVIAL FLUID SHOWED 31,000 WBCS, NO ORGANISMS AND NO GROWTH ON CULTURE. THE INJECTION PHYSICIAN'S COLLEAGUE WHO HAVE EXPERIENCED THE SAME REACTION WITH OTHER HYALURONIC ACID PREPARATIONS BUT NOT GEL-ONE STATED THAT THE PSEUDO-INFECTION REACTION WAS ALWAYS SUCCESSFULLY TREATED WITH A SINGLE ASPIRATION. THE INJECTION PHYSICIAN DISCUSSED WITH AN INFECTIOUS DISEASE DOCTOR AND DECIDED THAT THE BEST COURSE OF TREATMENT WOULD BE TO WASH THE PATIENT'S KNEE OUT ARTHROSCOPICALLY AND GIVE A DOSE OF ROCEPHIN FOLLOWED ORAL ANTIBIOTICS. EVEN IF IT WAS NOT INFECTION THAT SHOULD CLEAN OUR ANY IRRITANTS IN THE JOINT. ON (B)(6) 2017 EXAMINATION REVEALED A SWOLLEN TENDER LEFT KNEE. THE PATIENT COULD NOT EXTEND THE KNEE SECONDARY TO DISCOMFORT. ON (B)(6) 2018 THE PATIENT WAS SOMEWHAT BETTER GIVEN THE CURRENT CIRCUMSTANCES. HE RECEIVED PHYSICAL THERAPY CURRENTLY AFTER UNDERWENT A SYNOVECTOMY PROCEDURE. ON (B)(6) 2018 ACCORDING TO THE PATIENT'S WIFE, THE COMPLICATIONS WERE INDEED ONGOING. HIS KNEE HAD BEEN ASPIRATED MANY TIMES AND TESTED FOR INFECTION, WHICH ALL CAME BACK NEGATIVE ACCORDING TO THE INJECTION PHYSICIAN'S HOSPITAL. THERE WAS A COMPLETE ARTHROSCOPIC WASHOUT OF THE KNEE AND AGAIN SAMPLES WERE TAKEN FOR INFECTION BUT NONE FOUND. THEY ALSO COMPLETED IV ANTIBIOTICS DURING THE SURGERY AND HAD HIM ON ANTIBIOTICS PILL FORM FOR A WEEK AFTER. THE PATIENT WAS STILL THIS INFECTION OR REACTION TO GEL-ONE HAD PERSISTED. THE PATIENT AND HIS WIFE WENT IN THE HOSPITAL BECAUSE THE ACL WAS GOING TO BE REPAIRED AND THE CADAVER COULD NOT BE PUT IN BECAUSE STILL THERE WAS A PRESENCE OF WHAT APPEARS TO BE AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61129 GEL-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 00-1111-001-00 0017G21G H131001111001001

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other MEDROL| MEDROL| PERCOCET| PERCOCET| ZOFRAN| ZOFRAN| MEDROL| PERCOCET| ZOFRAN