BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC-ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3303112 · Received August 16, 2013

    Report

    Report Number
    2246315-2013-00426
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 26, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2013 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION RESULTS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #T12041, WITH EXPIRATION DATE (06/2015) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PAIN IN BOTH KNEES [ARTHRALGIA], HAD A REACTION [ADVERSE REACTION], DOESN'T FEEL INJECTION HELPED LEFT KNEE [THERAPEUTIC RESPONSE DECREASED], SWELLING IN BOTH KNEES [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A FEMALE PT (IN MID 50'S; AGE NOT PROVIDED}, INITIALS UNK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC-ONE. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F 20) INJECTION, IN BOTH KNEES (ROUTE AND DOSAGE REGIMEN NOT PROVIDED). THE LOT NUMBER FOR SYNVISC-ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE (10 DAYS AFTER SYNVISC-ONE INJECTION), THE PT DEVELOPED PAIN AND SWELLING IN BOTH KNEES AND RECEIVED TREATMENT WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (UNSPECIFIED). ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM BOTH THE EVENTS. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE ANY CAUSAL RELATIONSHIPS BETWEEN SYNVISC-ONE AND BOTH THE EVENTS, FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN VIA SALES REP REGARDING THE PRODUCT INFORMATION AND CLINICAL COURSE. THE LOT NUMBER OF SYNVISC-ONE WAS PROVIDED. IT WAS REPORTED THAT THE PT HAD NO PROBLEMS PRIOR TO SYNVISC-ONE INJECTION AND HAD A REACTION WITHIN 24 HOURS OF SYNVISC-ONE INJECTION. THE OUTCOME FOR THE EVENT OF "HAD A REACTION" WAS NOT PROVIDED. THE INTENSITY FOR THE EVENT OF "HAD A REACTION" WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE ANY CAUSAL RELATIONSHIP BETWEEN SYNVISC-ONE AND THE EVENT OF "HAD A REACTION." FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN REGARDING THE UPDATE IN THE MEDICAL HISTORY, SUSPECT DRUG INFORMATION, EVENT INFORMATION AND TREATMENT MEDICATION (STEROID) WHICH UPGRADED THE CASE TO SERIOUS. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOARTHRITIS OF BOTH KNEES (SINCE 5 YEARS, MODERATE GRADE (X RAY GRADE MODERATE) WITH JOINT NARROWING AND SMALL OSTEOPHYTES PRESENT), PREVIOUS TREATMENT WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, STEROIDS AND VISCOSUPPLEMENTATION. ON (B)(6) 2013, THE PT RECEIVED INTRA-ARTICULAR SYNVISC-ONE INJECTION (SUPRAPATELLAR RECESS UNDER ULTRASOUND GUIDANCE), ONCE. IT WAS REPORTED THAT PT HAD A REACTION WITHIN 24 HOURS OF SYNVISC-ONE INJECTION. ON (B)(6) 2013, THE PT DEVELOPED PAIN AND SWELLING IN BOTH KNEES. ON AN UNSPECIFIED DATE, THE PT RECEIVED TREATMENT WITH CELEBREX (CELECOXIB) AND PRED DOSE PACK FOR THE EVENT OF PAIN IN BOTH KNEES. AS OF (B)(6) 2013, THE PT WAS GRADUALLY IMPROVING AND WAS STILL HAVING RIGHT KNEE PAIN. IT WAS REPORTED THAT THE INJECTION HAD NOT HELPED THE LEFT KNEE. THE INTENSITY FOR THE EVENTS OF PAIN IN BOTH KNEES AND SWELLING IN BOTH KNEES WAS SEVERE AND FOR THE EVENT OF DOESN'T FEEL INJECTION HELPED LEFT KNEE WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN THE EVENTS OF PAIN, SWELLING IN BOTH KNEES AND SYNVISC-ONE AS POSSIBLE. THE REPORTING PHYSICIAN DID NOT PROVIDE ANY CAUSAL RELATIONSHIP BETWEEN SYNVISC-ONE AND THE EVENT OF DOESN'T FEEL INJECTION HELPED LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395550 SYNVISC-ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK T12041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention