BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1813633 · Received August 13, 2010

    Report

    Report Number
    2246315-2010-00162
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 26, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEARD A SNAP, CRACKLE POP IN KNEE [INJURY]. PAIN IN HER RIGHT LEG, ANKLE AND FOOT [PAIN IN EXTREMITY]. COMPLETE NUMBNESS FROM KNEE THRU ENTIRE FOOT [HYPOAESTHESIA]. EXTREME PAIN/CONSTANT SEVERE PAIN [ARTHRALGIA]. MY LEG HAS BEEN ON FIRE [BURNING SENSATION]. UNABLE TO SLEEP DUE TO THE PAIN. "I HAVE ONLY SLEPT ABOUT AN HOUR A DAY" [INSOMNIA]. UNABLE TO STAND FOR ANY TIME [DYSSTASIA]. TISSUE AROUND KNEE JOINT WAS SWOLLEN [JOINT SWELLING]. SWELLING IN HER RIGHT LEG, ANKLE AND FOOT [OEDEMA PERIPHERAL]. MUSCLE CRAMPS [MUSCLE SPASMS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WHO EXPERIENCED "A SNAP, CRACKLE POP" IN HER KNEE, KNEE PAIN, KNEE SWELLING, COMPLETE NUMBNESS FROM HER KNEE THROUGH HER ENTIRE FOOT, A BURNING SENSATION IN HER LEG, MUSCLE CRAMPS AND INSOMNIA AFTER STARTING SYNVISC-ONE. THE PATIENT RECEIVED AN INJECTION OF SYNVISC-ONE INTO HER KNEE ON (B)(6) 2010. THE PATIENT REPORTED THAT SHE EXPERIENCED "A SNAP, CRACKLE POP" IN HER KNEE, FOLLOWED BY KNEE PAIN STARTING ON (B)(6) 2010. SHE REPORTED THAT THE INTENSITY OF THE KNEE PAIN WAS SEVERE. THE PATIENT REPORTED THAT SHE ALSO EXPERIENCED KNEE SWELLING, COMPLETE NUMBNESS FROM HER KNEE THROUGH HER ENTIRE FOOT, A BURNING SENSATION IN HER LEG, MUSCLE CRAMPS AND INSOMNIA SINCE RECEIVING SYNVISC-ONE (NO DATE PROVIDED). AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS NOT YET RECOVERED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 FROM THE PATIENT, WHO UPDATED HER MEDICAL HISTORY TO INCLUDE OSTEOARTHRITIS IN BOTH KNEES AND AN UNSPECIFIED NUMBER OF PRIOR TREATMENTS WITH SYNVISC IN BOTH KNEES "OVER THE LAST FIVE TO SIX YEARS." THE PATIENT UPDATED HER DESCRIPTION OF THE EVENTS TO INCLUDE PAIN AND SWELLING IN HER RIGHT LEG, ANKLE AND FOOT STARTING ON (B)(6) 2010. SHE REPORTED THAT SHE ALSO EXPERIENCED DIFFICULTY STANDING. THE PATIENT REQUIRED TREATMENT FOR HER SYMPTOMS. SHE REPORTED THAT ON (B)(6) 2010, SHE WENT TO AN EMERGENCY ROOM AND X-RAYS WERE TAKEN, WHICH DETERMINED THAT SHE HAD NO BLOOD CLOTS. THE PATIENT REPORTED THAT SHE WAS PRESCRIBED OXYCONTIN FOR THE PAIN ON (B)(6) 2010. SHE REPORTED THAT A DOCTOR HAS ALSO PRESCRIBED LORTAB, AND AN UNSPECIFIED "ANTI-INFLAMMATORY MEDICATION." AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS NOT YET RECOVERED. THE PRODUCT LOT NUMBER WAS UNKNOWN. MANUFACTURER'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFORMATION HAS BEEN REQUESTED.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention