BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2170169 · Received June 28, 2011

    Report

    Report Number
    2246315-2011-00152
    Event Type
    Other
    Date Received
    June 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 6, 2011
    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

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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. 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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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

    SUPERFICIAL EDEMATOUS REMODELING [ARTHROPATHY]. EFFUSION [JOINT EFFUSION]. GASTRIC PAIN [ABDOMINAL PAIN UPPER]. PAIN ON THE INNER SIDE OF THE KNEE [ARTHRALGIA]. SWOLLEN LOCAL ZONE ON THE INNER SIDE OF KNEE JOINT [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A CONSUMER REGARDING A (B)(6) PT, INITIALS (B)(6), WITH GONARTHRITIS. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR FIFTEEN SESSIONS OF PHYSIOTHERAPY TO IMPROVE QUADRICEPS MUSCLE FUNCTION AND KNEE PAIN. ON (B)(6) 2011, THE PT INITIATED SYNVISC-ONE, 6ML WITHOUT PRIOR ARTHROCENTESIS. THE INJECTION AS PERFORMED BY LATERAL ROUTE AND WAS NOT PAINFUL. THE PT RESTED WITH ONLY MINIMAL PHYSICAL ACTIVITY FOR FOUR DAYS. ON (B)(6) 2011, WHEN THE PT RESTARTED MOVING NORMALLY, THE PT EXPERIENCED PAIN ON THE INNER SIDE OF THE KNEE "A LITTLE BEYOND FEMORO-TIBIAL SPACE". PAIN WAS NOT PRESENT WHEN RESTING. THE PAIN WAS DIFFERENT AND MORE INTENSE THAN THE OSTEOARTHRITIS PAIN THAT THE PT HAD PRIOR TO THERAPY WITH SYNVISC-ONE. THERE WAS NO EFFUSION, BUT A VERY MILDLY SWOLLEN LOCAL ZONE ON THE INNER SIZE OF THE KNEE JOINT. THE PT TREATED HERSELF WITH IBUPROFEN 400 MG THREE TIMES A DAY FOR FOUR DAYS. ON (B)(6) 2011, SHE RETURNED TO HER RHEUMATOLOGIST WHO CHANGED HER PAIN RELIEF TREATMENT TO KETOPROFEN AND ADVISED THE PT TO WAIT FOR TWO MORE WEEKS. THE PT TOOK 1 TABLET OF KETOPROFEN AND EXPERIENCED GASTRIC PAIN. ON HER OWN, SHE CHANGED TREATMENT AND TOOK AN OLD PRESCRIPTION OF VOLTAREN (DICLOFENAC) 50 MG TID WHICH HAD BEEN PRESCRIBED SOME TIME AGO, AND MOPRAL (OMEPRAZOL) FOR FOUR DAYS. THE TREATMENT DID NOT HAVE MUCH EFFECT ON PAIN. TREATMENT WITH VOLTAREN AND MOPRAL WERE DISCONTINUED ON (B)(6) 2011. A VISIT WITH A DIFFERENT RHEUMATOLOGIST WAS SCHEDULED ON (B)(6) 2011. THE ACTION TAKEN WITH SYNVISC-ONE WAS NOT PROVIDED. THE PT'S OUTCOME FOR THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ADD'L INFO WAS RECEIVED ON (B)(6) 2011 FROM THE SAME REPORTER. SHE REPORTED THAT SHE TOOK ADVIL (IBUPROFEN) FOR PAIN AS NEEDED FOR A FEW DAYS AND THAT SHE RESTARTED THERAPY WITH VOLTAREN. ON AN UNK DATE, SHE HAD UNDERGONE MRI (MAGNETIC RESONANCE IMAGING) THAT SHOWED MILD SUPERFICIAL EDEMATOUS REMODELING AND MILD EFFUSION. THE PT TOOK ADVICE FROM ANOTHER RHEUMATOLOGIST WHO INJECTED CORTICOSTEROIDS INTO HER KNEE ON (B)(6) 2011. THERAPY WITH VOLTAREN WAS DISCONTINUED ON (B)(6) 2011. AT THE TIME OF THIS REPORT, THE KNEE PAIN PERSISTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention