BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F-20) INJECTION

    MDR report key: 1212763 · Received October 27, 2008

    Report

    Report Number
    2246315-2008-00155
    Event Type
    Other
    Date Received
    October 27, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPECIFICATIONS CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATE 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

    ALLERGIC REACTION [DRUG HYPERSENSITIVITY]. KNEE EFFUSION [JOINT EFFUSION]. KNEE PAIN [ARTHRALGIA]. KNEE SWELLING [JOINT SWELLING]. KNEE SURGERY [KNEE OPERATION]. DEPRESSION [DEPRESSION]. HAS TO SPEND TIME LYING IN BED [MOBILITY DECREASED]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2008 FROM A (B)(6) FEMALE WITH A HISTORY OF BONE-ON-BONE OSTEOARTHRITIS AND FOUR MAJOR BACK SURGERIES, (B)(6), WHO EXPERIENCED KNEE SURGERY, ALLERGIC REACTION, KNEE EFFUSION, KNEE PAIN, KNEE SWELLING, DEPRESSION AND DECREASED MOBILITY AFTER STARTING SYNVISC. THE PT REPORTED THAT SHE RECEIVED HER FIRST INJECTIONS FOR SYNVISC INTO BOTH KNEES APPROX FOUR MONTHS BEFORE THIS REPORT ((B)(6) 2008). SHE RECEIVED THE SECOND INJECTION OF SYNVISC INTO BOTH KNEES TWO WEEKS AFTER THE FIRST. AT AN UNSPECIFIED TIME AFTER THE SECOND INJECTIONS, THE PT REPORTED THAT SHE BEGAN TO EXPERIENCE SEVERE PAIN AND SWELLING IN HER LEFT KNEE. SHE WENT TO THE EMERGENCY ROOM ONCE TO HAVE FLUID DRAWN OFF HER LEFT KNEE AND THEN WENT TO ANOTHER PHYSICIAN (NOT THE INJECTING PHYSICIAN) AND HAD FLUID DRAWN OFF HER LEFT KNEE TWO MORE TIMES. ACCORDING TO THE PT, THE TREATING PHYSICIAN TOLD HER SHE HAD AN EXPERIENCED AND ALLERGIC REACTION TO SYNVISC. HAVING FLUID DRAWN OFF THE KNEE A TOTAL OF THREE TIMES (DATES UNSPECIFIED) DID NOT HELP HER PAIN AND SWELLING MUCH AND THE PT HAD AN UNSPECIFIED SURGERY ON HER LEFT KNEE ON (B)(6) 2008) "TO TRY TO CLEAN IT UP." THE PT STATED SHE WAS TOLD THAT THE LEFT KNEE "LOOKED VERY BAD". THE PT REPORTED THAT THE LEFT KNEE SURGERY HAD NOT HELPED HER LEFT KNEE SYMPTOMS OF SEVERE PAIN AND SWELLING, WHICH CONTINUED TO BE VERY BAD. THE PT STATED THAT SHE HAD BEEN DEPRESSED BECAUSE SHE WAS UNABLE TO GO OUT AND DO THINGS AND HAD TO SPEND TIME LYING IN BED. SHE ALSO STATED THAT HER RIGHT KNEE HAD STARTED TO BOTHER HER RECENTLY BECAUSE SHE HAD BEEN FAVORING HER LEFT KNEE WHEN SHE TRIED TO GET AROUND. THE PT CONTACTED THE MFR REQUESTING THAT THE MFR PAY ALL OF HER MEDICAL EXPENSES RELATED TO THESE EVENTS. AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED FROM THE EVENT KNEE EFFUSION, THE OUTCOME OF THE REMAINING EVENTS WAS UNK.

    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 62 YR Other| R