BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3133865 · Received May 24, 2013

    Report

    Report Number
    2246315-2013-00335
    Event Type
    Other
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT. 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

    SEVERE AND EXCRUCIATING HIP PAIN THAT WAS RADIATING DOWN HIS WHOLE LEG [HIP] [ARTHRALGIA]. FEELING FOGGY [HIP] [FEELING ABNORMAL]. LIMP RETURNED [HIP] [GAIT DISTURBANCE]. SYNVISC WAS MIXED WITH STEROID [HIP] [DEVICE MISUSE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON MAY 16, 2013 FROM A CONSUMER REGARDING A 58 YEAR OLD MALE PATIENT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC AND LIMPING (OVER ONE YEAR). ON AN UNSPECIFIED DATE IN (B)(6) 2013, AFTER BEING PRE-MEDICATED WITH NOVOCAINE, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION MIXED WITH STEROID (DEVICE MISUSE) (ROUTE AND DOSAGE REGIMEN NOT PROVIDED) IN THE RIGHT HIP (OFF LABEL USE) AFTER BEING PRE-MEDICATED WITH NOVOCAINE PERFORMED UNDER X-RAY. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. IT WAS REPORTED THAT THIS INJECTION WORKED WELL AND THE PATIENT'S LIMP WENT AWAY. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT WAS ADMINISTERED SECOND INJECTION OF SYNVISC (NOT MIXED WITH STEROID). SIX HOURS POST INJECTION, THE PATIENT EXPERIENCED EXCRUCIATING HIP PAIN THAT WAS RADIATING DOWN HIS WHOLE LEG. THE PATIENT MEDICATED HIMSELF WITH TYLENOL (PARACETAMOL) AND VICODAN (HYDROCODONE BITARTRATE, PARACETAMOL) FOR EXCRUCIATING HIP PAIN THAT WAS RADIATING DOWN HIS WHOLE LEG, WHICH DID NOTHING TO ALLEVIATE HIS HIP PAIN. THE PATIENT ALSO RECEIVED TREATMENT WITH PERCOCET (OXYCODONE HYDROCHLORIDE) AND MEDROL PACK (METHYLPREDNISOLONE). ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT FELT A LITTLE FOGGY. ON (B)(6) 2013, IN THE MORNING, THE PATIENT'S LIMP HAD RETURNED. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE EVENTS OF EXCRUCIATING HIP PAIN THAT WAS RADIATING DOWN HIS WHOLE LEG, FEELING FOGGY AND LIMP RETURNED HAD NOT YET RECOVERED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE AMBIEN (ZOLPIDEM TARTRATE) AND XANAX (ALPRAZOLAM). THE INTENSITY FOR THE EVENTS OF EXCRUCIATING HIP PAIN THAT WAS RADIATING DOWN HIS WHOLE LEG WAS SEVERE. INTENSITY FOR THE EVENTS OF FEELING FOGGY AND LIMP RETURNED WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF EXCRUCIATING HIP PAIN THAT WAS RADIATING DOWN HIS WHOLE LEG, FEELING FOGGY AND LIMP RETURNED WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230559 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention