BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3093750 · Received April 29, 2013

    Report

    Report Number
    2246315-2013-00303
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 1, 2012
    Report Date
    April 19, 2013
    Manufacturer
    GENZYME SURGERY
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER R12161, EXPIRY DATE 2015-04 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    DEVELOPED AN INFECTION AFTER TAKING SYNVISC [ARTHRITIS INFECTIVE]. INCREASED PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN (PATIENT'S HUSBAND) VIA ANOTHER HEALTH PROFESSIONAL REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC-ONE (ON (B)(6) 2012 IN HER RIGHT KNEE AND SHE HAD NO PROBLEM WITH THAT INJECTION. SHE HAD CONCOMITANT DISEASE OF DIABETES. ON (B)(6) 2012, THE PATIENT RECEIVED SYNVISC ONE (HYLAN G-F 20) INJECTION AT A DOSE OF 06 ML, ONCE (ROUTE NOT PROVIDED) INTO HER LEFT KNEE. ON AN UNSPECIFIED DATE IN 2012 (AFTER SYNVISC INJECTION), THE PATIENT DEVELOPED JOINT INFECTION. LATER IN (B)(6) 2012 (APPROXIMATELY ONE WEEK AFTER THE INJECTION), SHE EXPERIENCED INCREASED LEFT KNEE PAIN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED AND SHE WAS TREATED WITH INTRAVENOUS ANTIBIOTICS (UNSPECIFIED) FOR THE EVENT OF JOINT INFECTION. THE PATIENT ALSO HAD AN ARTHROSCOPY WITH LAVAGE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME FOR BOTH THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS REPORTED INCLUDE JANUVIA (SITAGLIPTIN PHOSPHATE), LEVEMIR (INSULIN DETEMIR) AND LANTUS (INSULIN GLARGINE). THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC ONE AND BOTH THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184316 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME SURGERY UNK R12161

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R JANUVIA (SITAGLIPTIN PHOSPHATE): UNK| LEVEMIR (INSULIN DETEMIR): UNK| LANTUS (INSULIN GLARGINE): UNK