BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC-ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1912779 · Received November 3, 2010

    Report

    Report Number
    2246315-2010-00226
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    RECEIVED LEFT KNEE PAIN RELIEF FOR SEVERAL MONTHS BEFORE KNEE PAIN RETURNED [DEVICE INEFFECTIVE]. LEFT KNEE PAIN RETURNED - WORSE [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A (B)(6) FEMALE PT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF OSTEOARTHRITIS. THE PT HAD NO PREVIOUS TREATMENT WITH SYNVISC ONE. THE PT WAS ADMINISTERED SYNVISC-ONE ON AN UNK DATE IN (B)(6) 2010. THE PT STATED THAT SHE RECEIVED LEFT KNEE PAIN RELIEF FOR SEVERAL MONTHS BEFORE THE KNEE PAIN RETURNED AND THE PAIN WAS WORSE THAN IT WAS PRIOR TO SYNVISC-ONE TREATMENT. THE PT REPORTED THAT HAD LEFT TOTAL KNEE REPLACEMENT ON AN UNK DATE IN (B)(6) 2010. AT THE TIME OF THIS REPORT, THE OUTCOMES OF THE REPORTED EVENTS WERE UNK. THE SYNVISC-ONE LOT NUMBER WAS UNK. NO FURTHER INFO WAS PROVIDED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention