BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2112474 · Received March 10, 2011

    Report

    Report Number
    2246315-2011-00042
    Date Received
    March 10, 2011
    Date of Event
    September 10, 2009
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE REC'D ON (B)(4) 2011. 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Description of Event or Problem · 1

    WORSENING PAIN [ARTHRALGIA]. SEROSANGUINOUS REACTION [NONSPECIFIC REACTION]. WEIGHT LOSS [WEIGHT DECREASED]. EFFUSION COLLECTED BEFORE THIRD INJECTION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT REC'D ON (B)(6) 2011 FROM A (B)(6) FEMALE PT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF OSTEOARTHRITIS, PREVIOUS TREATMENT WITH SYNVISC OVER SEVERAL YEARS, AND LAP BAND SURGERY ONE YEAR AGO. THE PT WAS ADMINISTERED THE SYNVISC SERIES SIX TO SEVEN MONTHS AGO IN BOTH KNEES. THE PT EXPERIENCED WORSENING PAIN. SHE ALSO STATED THAT SHE EXPERIENCED WEIGHT LOSS DUE TO THE LAP BAND SURGERY. ADD'L TREATMENT INCLUDED SUPARTZ (SODIUM HYALURONATE). AT THE TIME OF THIS REPORT, THE OUTCOME OF THE REPORTED EVENTS AND TREATMENT WERE UNK. THE SYNVISC LOT NUMBER WAS NOT AVAILABLE. NO FURTHER INFO WAS PROVIDED. ADD'L INFO WAS REC'D ON (B)(6) 2011 FROM THE PHYSICIAN. THE PT HAD A HISTORY OF MILD OSTEOARTHRITIS IN HER RIGHT KNEE FOR A DURATION OF TWO YEARS, JOINT NARROWING, PREVIOUS USE OF SYNVISC, NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), AND STEROIDS. THE PT DID NOT HAVE A HISTORY OF PRIOR EFFUSION OR OSTEOPHYTES. THE PHYSICIAN STATED THAT THE SYNVISC INJECTIONS WERE ADMINISTERED ON (B)(6) 2009. EFFUSION WAS COLLECTED BEFORE THE THIRD SYNVISC INJECTION. THE ONSET DATE OF WORSENING KNEE PAIN WAS (B)(6) 2009. TREATMENTS INCLUDED STEROID INJECTION AND NSAIDS. THE PT RECOVERED AFTER APPROX THREE WEEKS. THE RELATION OF THE EVENT OF WORSENING KNEE PAIN TO THE SYNVISC INJECTION WAS PROBABLE AND THE INTENSITY OF SYMPTOMS WAS MODERATE. THE PHYSICIAN ALSO ADDED THAT THE PT HAD A "SEROSANGUINEOUS REACTION." THE OUTCOME OF THE EVENTS OF KNEE EFFUSION AND SEROSANGUINEOUS REACTION WAS UNK. NO ADD'L LABS WERE PERFORMED AND EXUDATE WAS NOT COLLECTED AFTER THE LAST SYNVISC TREATMENT. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other