BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2011834 · Received February 24, 2011

    Report

    Report Number
    2246315-2011-00028
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2002
    Report Date
    February 16, 2011
    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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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

    RIGHT KNEE BRUISING [CONTUSION]. RIGHT KNEE STIFFNESS [JOINT STIFFNESS]. DIFFICULTY BENDING RIGHT LEG [JOINT RANGE OF MOTION DECREASED]. RIGHT KNEE PAIN [ARTHRALGIA]. RIGHT KNEE SWELLING [JOINT SWELLING]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2011 FROM A (B)(6) FEMALE PT WITH A HISTORY OF OSTEOARTHRITIS OF THE KNEES, INITIAL (B)(6), WHO EXPERIENCED PAIN/DISCOMFORT, SWELLING, STIFFNESS, BRUISING IN THE RIGHT KNEE AND HAD DIFFICULTY IN BENDING THE RIGHT KNEE AFTER RECEIVING SYNVISC-ONE. THE PT RECEIVED INJECTIONS OF SYNVISC-ONE IN BOTH THE KNEES IN (B)(6)-2011. IMMEDIATELY AFTER RECEIVING THE SYNVISC-ONE INJECTIONS, THE PT EXPERIENCED PAIN/DISCOMFORT, SWELLING, STIFFNESS, AND BRUISING IN THE RIGHT KNEE. THE PT WAS ALSO UNABLE TO BEND HER RIGHT KNEE. THE PT RECEIVED A CORTISONE SHOT ON (B)(6)-2011. THE PT REPORTED THAT HER RIGHT KNEE DISCOMFORT HAS DECREASED A LITTLE SINCE THE CORTISONE SHOT WAS RECEIVED. THE PT ALSO USED ALEVE AND ICE AS TREATMENT. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. ON (B)(6)-2011, ADDITIONAL INFO WAS RECEIVED IN THE FORM OF QA RESULTS WITHOUT A LOT NUMBER. 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 CONFORMANCE TO SPECIFICATION PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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. MFR'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 6/ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention