BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML

    MDR report key: 1912855 · Received November 9, 2010

    Report

    Report Number
    2246315-2010-00229
    Event Type
    Other
    Date Received
    November 9, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 30, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LOSS OF RANGE OF MOTION OF KNEE [JOINT RANGE OF MOTION DECREASED]. INCREASED PAIN OF KNEE [ARTHRALGIA]. INCREASED SWELLING OF THE KNEE [JOINT SWELLING]. FLUID SENT C AND S SHOWED STAPHYLOCOCCAL INFECTION [ARTHRITIS INFECTIVE]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM AN HCP OF A (B)(6) MALE PT WITH A HISTORY OF OSTEOARTHRITIS OF THE KNEE, INITIAL (B)(6), WHO EXPERIENCED INCREASED PAIN AND SWELLING OF THE KNEE, AND LOSS OF RANGE OF MOTION IN THE KNEE JOINT AFTER RECEIVING SYNVISC-ONE. THE PT RECEIVED A SYNVISC-ONE INJECTION IN THE LEFT KNEE ON (B)(6) 2010. THE LOT NUMBER OF THE INJECTION GIVEN TO THE PT WAS Q1018 (EXPIRATION DATE: 31-MAR-2010). THE PT REPORTED INCREASED PAIN AND SWELLING IN THE INJECTED KNEE ON (B)(6) 2010. EXAMINATION REVEALED INCREASED SWELLING AND LOSS OF RANGE OF MOTION. THESE SYMPTOMS CONTINUED FOR TWO DAYS. THE PT UNDERWENT SURGERY (KNEE WASHOUT) AND THE FLUID WAS SENT FOR CULTURE AND SENSITIVITY ANALYSIS WHICH SHOWED STAPHYLOCOCCUS INFECTION. THE PT'S SYMPTOMS CONTINUED AFTER ANTIBIOTIC THERAPY. THE PT THEN UNDERWENT A SECOND SURGERY (ARTHROSCOPY) DUE TO THE STAPHYLOCOCCUS INFECTION. IN THE OPINION OF THE HCP, THESE EVENTS WERE "SEVERE" IN INTENSITY AND "PROBABLY" RELATED TO THE USE OF SYNVISC-ONE IN THE PT. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS "NOT YET RECOVERED". ON (B)(6) 2010, ADDITIONAL INFO WAS PROVIDED BY THE PT'S HCP WHEREIN HE CLARIFIED THAT THE LOT NUMBER FOR THE SYNVISC-ONE INJECTION GIVEN TO THE PT'S IS NOT KNOWN. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R| S