BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1971944 · Received January 24, 2011

    Report

    Report Number
    2246315-2011-00009
    Event Type
    Other
    Date Received
    January 24, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 27, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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

    MAJOR RIGHT KNEE EFFUSION [JOINT EFFUSION]. RIGHT LOWER LIMB OEDEMA [OEDEMA PERIPHERAL]. CASE DESCRIPTION: COMPRESSION WITH SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WHO IS ALSO A HOSPITAL PHARMACIST WITH A MEDICAL HISTORY OF TWO PREVIOUS TREATMENTS WITH SYNVISC WITHOUT INCIDENT. PREVIOUS TO THE SYNVISC-ONE INJECTION GIVEN ON APPROXIMATELY (B)(6) 2010, THE PATIENT HAD SYNOVIAL FLUID REMOVED FROM THE KNEE JOINT. THE SYNVISC-ONE INJECTION ITSELF WAS NOT PAINFUL. A FEW DAYS FOLLOWING THE SYNVISC-ONE INJECTION, THE PATIENT EXPERIENCED MAJOR EFFUSION REQUIRING TWO SEPARATE KNEE JOINT PUNCTURES. SYNOVIAL FLUID WAS STERILE. ON (B)(6) 2010, THE PATIENT REPORTED THAT KNEE EFFUSION HAD IMPROVED, BUT THAT SHE NOW HAD INFERIOR LIMB EDEMA ON THE SAME LEG INVOLVING THE KNEE, CALF, AND ANKLE. A DOPPLER ULTRASOUND EXAMINATION WAS SCHEDULED FOR (B)(6) 2010. AT THE TIME OF THIS REPORT, THE OUTCOME OF EVENTS AND TREATMENT WERE UNKNOWN. THE SYNVISC-ONE LOT NUMBER WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 FROM THE PHYSICIAN. THE PATIENT, INITIALS (B)(6), HAD A MEDICAL HISTORY OF RIGHT GONARTHRITIS GRADE 4 WITH DEGENERATIVE ETIOLOGY, LEFT SUPRASPINOUS CALCIFIC TENDINITIS, AND THORACOLUMBAR JUNCTION SYNDROME ALSO KNOWN AS MAIGNE SYNDROME. KNEE JOINT PUNCTURE WAS PERFORMED PRIOR TO SYNVISC-ONE INJECTION, BUT THE KNEE WAS DRY. SYNVISC-ONE WAS INJECTED ON (B)(6) 2010 BY ANTERIOR ROUTE. SYNVISC-ONE WAS AT ROOM TEMPERATURE ON INJECTION AND THE SIZE OF THE NEEDLE WAS 21 GAUGE (GREEN NEEDLE). A KNEE JOINT PUNCTURE WAS PERFORMED ON (B)(6) 2010. AT LEAST 60 ML OF SYNOVIAL FLUID WAS WITHDRAWN AND FLUID WAS CLOUDY. THE SYNOVIAL FLUID ANALYSIS RESULTS CONSISTED OF THE FOLLOWING: RBC (RED BLOOD CELL) COUNT 210/MM3, WBC (WHITE BLOOD CELL) COUNT 7550/MM3 WITH 84% NEUTROPHILS AND 16% MONOCYTES; PROTIDS 58 G/L. THE WITHDRAWN SYNOVIAL FLUID WAS STERILE. TREATMENT CONSISTED OF DIPROSTENE, MORE THAN ONE KNEE JOINT PUNCTURE, AN NSAID (NONSTEROIDAL ANTI-INFLAMMATORY DRUG) PO (ORAL), AND COMPRESSION WITH SUPPORT STOCKINGS FOR POPLITEAL CYST RUPTURE AND RIGHT LOWER LIMB EDEMA. THE OUTCOME FOR BOTH EVENTS FIFTEEN DAYS LATER WAS RECOVERING. NO FURTHER INFORMATION WAS PROVIDED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2011. 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 SYNVISC ONE IS NOT AFFECTED BY THIS 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention