BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2011699 · Received March 1, 2011

    Report

    Report Number
    2246315-2011-00036
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 23, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# V1018, WITH EXPIRATION DATE 08/2013 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    RIGHT KNEE HOT TO TOUCH [JOINT WARMTH]. LIMITED RANGE OF MOTION [JOINT RANGE OF MOTION DECREASED]. WORSENING KNEE PAIN/CONSTANT DULL ACHING THROBBING PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED (B)(6)-2011, FROM A HEALTH CARE PROVIDER (HCP) REGARDING A (B)(6) MALE PATIENT, INITIALS (B)(6). THE PATIENT HAD A HISTORY OF OSTEOARTHRITIS. THE PATIENT EXPERIENCED WORSENING KNEE PAIN, HIS RIGHT KNEE WAS WARM TO TOUCH, HE HAD PAIN AND LIMITED RANGE OF MOTION AFTER RECEIVING SYNVISC-ONE. ON (B)(6)-2011, THE PATIENT RECEIVED ONE SYNVISC-ONE INJECTION INTO THE RIGHT KNEE. THE HCP REPORTED THE PATIENT RETURNED THREE DAYS AFTER RECEIVING THE SYNVISC-ONE WITH WORSENING PAIN. THE PATIENT'S RIGHT KNEE WAS ALSO HOT TO TOUCH AND HE HAD A CONSTANT DULL ACHING THROBBING PAIN AND LIMITED RANGE OF MOTION. THE HCP DIAGNOSED JOINT EFFUSION. THE PATIENT FOLLOWED UP 8 DAYS LATER AND HE CONTINUED TO EXPERIENCE INCREASED PAIN. THE PATIENT FOLLOWED UP 9 DAYS LATER AND EXPERIENCED A REDUCTION IN HIS SYMPTOMS. THE PATIENT WAS TREATED WITH AN ASPIRATION (NEGATIVE CULTURE), ACE WRAP, ICE AND ELEVATION, MEDROL DOSE PACK AND PAIN MEDICATION (TRAMADOL). THE HCP REPORTED THE PATIENT'S ADVERSE EVENTS HAD A PROBABLE RELATIONSHIP TO SYNVISC-ONE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)-2011 IN THE FORM OF QA RESULTS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# V1018, WITH EXPIRATION DATE 08/2013 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK V1018

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention