BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2163644 · Received June 10, 2011

    Report

    Report Number
    2246315-2011-00137
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER V1021, EXPIRY DATE 08/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    RIGHT KNEE PAIN [ARTHRALGIA]. FEELS LIKE HER KNEE IS GIVING OUT [JOINT INSTABILITY]. KNEE REDNESS [ERYTHEMA]. KNEE WARMTH [JOINT WARMTH]. KNEE SWELLING [JOINT SWELLING]. NO RESULTS [DEVICE INEFFECTIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A CONSUMER REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED SYNVISC-ONE, 6 ML IN THE RIGHT KNEE. THE PT REPORTED THAT SHE HAD NO RESULTS AT ALL. SHE STATED THAT HER KNEE FELT LIKE IT WAS STIFF AND IT FELT LIKE SOMEONE KICKED HER IN THE KNEE. THIS SENSATION WAS THE SAME AS BEFORE SHE RECEIVED THE SYNVISC-ONE. SHE ALSO FELT LIKE HER KNEE WAS GIVING OUT ON HER. SHE FELT DEPRESSED BECAUSE SHE WANTED IT TO WORK FASTER AND SHE WANTED TO BE ABLE TO WALK WITHOUT PAIN. THE ACTION TAKEN WITH SYNVISC-ONE WAS NOT PROVIDED. THE PT'S OUTCOME FOR THE EVENTS WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 FROM THE PT'S PHYSICIAN. THE PT'S MEDICAL HISTORY INCLUDED SEVERE GRADE OSTEOARTHRITIS, AND PREVIOUS TREATMENT WITH NSAIDS (NONSTEROIDAL ANTI-INFLAMMATORY DRUGS) AND STEROIDS. THE SYNVISC-ONE LOT NUMBER WAS V1021. NO EXUDATE WAS COLLECTED. THE EVENTS OF DEVICE INEFFECTIVE AND FEELING LIKE HER KNEE WAS GIVING OUT BOTH HAD AN ONSET DATA OF (B)(6) 2011. A KNEE EXAM WAS PERFORMED ON AN UNK DATE IN 2011 DURING WHICH THE PHYSICIAN STATED THAT THERE WAS REDNESS, WARMTH WITH SIGNIFICANT SWELLING. THE PT'S OUTCOME FOR THE EVENTS WAS NOT YET RECOVERED. THE INTENSITY FOR THE EVENTS OF DEVICE INEFFECTIVE AND KNEE WAS GIVING OUT WERE BOTH MODERATE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC-ONE AND THOSE TWO EVENTS WAS PROBABLY RELATED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2011. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER V1021, EXPIRY DATE 08/01/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 FROM THE PHYSICIAN WHO REPORTED THAT THE PT DID NOT HAVE KNEE REDNESS, KNEE WARMTH, OR KNEE SWELLING AS "ONLY PAIN WAS REPORTED TO OUR OFFICE". ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 FROM THE CONSUMER. SHE STATED THAT THE SYNVISC-ONE INJECTION DID NOTHING TO RELIEVE HER RIGHT KNEE PAIN AND SHE HAS SINCE RECEIVED A CORTISONE INJECTION AND WAS USING INTERX ELECTRODES ON HER KNEE, BOTH OF WHICH WERE HELPING ALLEVIATE HER RIGHT KNEE PAIN.

    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 V1021

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention