BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML

    MDR report key: 2181113 · Received July 22, 2011

    Report

    Report Number
    2246315-2011-00184
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 7, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT HAD INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    SEVERE PAIN [PAIN], CULTURE OF KNEE JOINT ASPIRATED FLUID POSITIVE FOR STREP VIRIDANS (INFECTION) (B)(6), JOINT EFFUSION [JOINT EFFUSION], SWOLLEN KNEE [JOINT SWELLING], INCREASED SEDIMENTATION RATE [RED BLOOD CELL SEDIMENTATION RATE INCREASED], C-REACTIVE PROTEIN INCREASED [C-REACTIVE PROTEIN INCREASED], DIMINISHED MOBILITY LEFT LEG [MOBILITY DECREASED], FELT LIKE A LIGHTNING STRUCK HER [FEELING ABNORMAL]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2011 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS UNK. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR DEGENERATIVE DISEASE IN THE LEFT KNEE WHICH HAS WORSENED. THE PT REPORTED THAT SHE TOOK MOTRIN FOR HER PAIN BUT HER PAIN HAD DEVELOPED TOLERANCE TO MOTRIN. THE PT ALSO REC'D PREVIOUS TREATMENT WITH SYNVISC IN 2005. THE PT REC'D SYNVISC-ONE ON (B)(6) 2011 (THE MONTH WAS SPECIFICALLY NOT MENTIONED BUT HAS BEEN INFERRED FROM THE TIME FRAME) IN THE RIGHT KNEE. THE INJECTION IN THE RIGHT KNEE WAS UNEVENTFUL. ON (B)(6) 2011, THE PT INITIATED TREATMENT WITH SYNVISC-ONE IN THE LEFT KNEE. ARTHROCENTESIS WAS PERFORMED ON THE LEFT KNEE PRIOR TO THE SYNVISC-ONE INJECTION. WITHIN 24 HRS OF RECEIVING THE SYNVISC-ONE INJECTION, THE PT'S RIGHT KNEE BLEW UP AND THE PT WENT TO THE HOSPITAL DUE TO SEVERE PAIN AND A SWOLLEN KNEE. THE HCP REPORTED THAT HE DRAINED 100CC OF WHITISH, MUCINOUS, THICK FLUID FROM THE PT'S KNEE, GRAM STAIN WAS NEGATIVE FOR ORGANISMS AND THE PT WAS DISCHARGED FROM THE HOSPITAL. LATE ON THE NEXT DAY, THE PT AGAIN PRESENTED TO THE ER WITH CONTINUING COMPLAINTS OF PAIN AND SWOLLEN KNEE. ARTHROSCOPIC LAVAGE AND A WASHOUT WERE PERFORMED ON THE PT'S AFFECTED KNEE. AT THIS POINT, THE CULTURE REPORT WAS (B)(6). THE PT'S BLOOD WAS DRAWN AND THE ERYTHROCYTE SEDIMENTATION RATE (ESR) WAS 140 AND THE C-REACTIVE PROTEIN (CRP) WAS 13. AS OF (B)(6) 2011, THE ESR WAS DOWN TO 90 AND THE CRP WAS AT 5. THE PT REPORTED THAT SHE HAS A FIVE DAY HOSPITAL STAY. SHE WAS TREATED WITH VANCOMYCIN IN THE HOSPITAL WHICH WAS SWITCHED TO ZITHROMAX WHEN SHE LEFT THE HOSPITAL. THE PT WAS ALSO GIVEN 15MG MOBIC WHICH SHE CONTINUE TO TAKE. THE PT ALSO REPORTED THAT MOBILITY OF HER LEFT LEG HAS GREATLY DIMINISHED AND SHE IS NOW WALKING WITH THE AID OF A WALKER. THE PT REPORTED THAT SHE FEELS LIKE SHE "FELT LIKE A LIGHTNING STRUCK HER". THE HCP REPORTED THAT THE EVENT (KNEE INFECTION AND EFFUSION) WAS CAUSED BY SYNVISC-ONE. AT THE TIME OF THIS REPORT, THE FINAL OUTCOME OF THE PT WAS NOT KNOWN. ON (B)(6) 2011, ADD'L INFO WAS REC'D IN THE FORM OF QA RESULTS W/O A LOT NUMBER. 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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R