BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID (Y2)

    MDR report key: 4734263 · Received April 16, 2015

    Report

    Report Number
    9610200-2015-00004
    Event Type
    Injury
    Date Received
    April 16, 2015
    Report Date
    March 23, 2015
    Manufacturer
    FIDIA FARMACEUTICI S.P.A
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, THE FDA GRANTED THE PERMISSION FOR THE MANUFACTURER FIDIA FARMACEUTICI S.P.A. TO SUBMIT A SINGLE MDR FOR ADVERSE EVENTS THAT INVOLVE MEDICAL DEVICES MANUFACTURED BY FIDIA FARMACEUTICI S.P.A. AND IMPORTED INTO THE USA BY FIDIA PHARMA USA, INC AS A CONSEQUENCE, FIDIA FARMACEUTICI S.P.A. (THE MANUFACTURER) SHOULD SUBMIT REPORTABLE CASES ON BEHALF OF FIDIA PHARMA USA INC (THE IMPORTER). HOWEVER, SINE THIS IS A NON-US CASE WHICH FIDIA FARMACEUTICI S.P.A. HAS BECOME AWARE OF IN ITS ROLE OF PRODUCT MANUFACTURER, FIDIA PHARMA USA DOES NOT HAVE ANY REPORTING OBLIGATION. THIS IS A CASE-REPORT FROM (B)(6) ORIGINATING FROM THE SCIENTIFIC LITERATURE MONITORING ON THE ACTIVE INGREDIENT "HYALURONIC ACID". IT SHOULD BE NOTED THAT THE PAPER DOES NOT REPORT ANY BRAND NAME. FIDIA FARMACEUTICI NO LONGER SELLS THE PRODUCT IN (B)(6) (THE LAST SUPPLY WAS IN (B)(6) 2011), HOWEVER IN THE ABSENCE OF A SPECIFIED INVENTED NAME, OR ANY OTHER ALTERNATIVE REASONS FOR EXCLUSION, THE OWNERSHIP OF THE PRODUCT SUSPECTED TO BE RESPONSIBLE FOR THE OCCURRENCE CANNOT BE RULED OUT. THIS IS THE FIRST CASE OF SKIN NECROSIS FOR HYALGAN SINCE 1987 WHEN IT WAS FIRST PUT ON THE MARKET.

    Description of Event or Problem · 1

    THIS IS A (B)(6) CASE REPORT FROM THE WORLDWIDE SCIENTIFIC LITERATURE MONITORING ON THE ACTIVE INGREDIENT "HYALURONIC ACID" ((B)(6). SKIN NECROSIS FROM INTRA-ARTICULAR HYALURONIC ACID INJECTION. J CUTAN MED SURG.(B)(6) 2015. PII:7750.2014.14081). A (B)(6) MAN PRESENTED WITH A 1-MONTH HISTORY OF PAINFUL SKIN ERUPTION DEVELOPED 48 HOURS AFTER A BILATERAL KNEE INJECTION WITH INTRARTICULAR HYALURONIC ACID (BRAND NAME NOT SPECIFIED) FOR TREATMENT OF KNEE OSTEOARTHRITIS. ON EXAMINATION, THERE WAS A WELL-DEMARCATED, LIVEDOID (NET-LIKE), VIOLACEOUS PATCH ON THE RIGHT KNEE WITH A DARK CENTER AND A LIGHTER BORDER. THE LEFT KNEE WAS NORMAL. A PUNCH BIOPSY OF THE SKIN WAS PERFORMED AND SHOWED ATROPHIC EPIDERMIS WITH PATCHY NECROSIS. THE VIABLE PORTIONS OF THE EPIDERMIS REVEALED REACTIVE KERATINOCYTES ADMIXED WITH SCATTERED NECROTIC KERATINOCYTES. IN THE DERMIS, THERE WAS AN AMORPHOUS BASOPHILIC FOREIGN MATERIAL CONSISTENT WITH HA PRESENT WITHIN BOTH THE DERMAL STROMA ANDA MEDIUM SIZED VEIN WITH AN ASSOCIATED THROMBUS FORMIN. HENCE, THE HISTOLOGIC FINDINGS WERE CONSISTENT WITH TISSUE NECROSIS DUE TO IA HA INJECTION ENTERING THE CUTANEOUS VASCULATURE. THE PT WAS TREATED CONSERVATIVELY WITH TOPICAL FUSIDIC ACID DRESSINGS. THE LESION RESOLVED IN 4 MONTHS' TIME. AUTHOR'S COMMENT: TISSUE NECROSIS IS A RARE BUT SERIOUS COMPLICATION OF HA IA INJECTIONS, WHICH ARE COMMONLY ADMINISTERED FOR COSMETIC PURPOSES AND MORE RECENTLY FOR TREATMENT OF MILD TO MODERATE KNEE OA. IT IS KNOWN THAT FACIAL SKIN NECROSIS IS A POTENTIAL COMPLICATION OF INTRADERMAL HA COSMETIC INJECTION; THIS CASE REPORT BRINGS TO ATTENTION THE POSSIBILITY THAT THE USE OF HA IA INJECTIONS IN THE TREATMENT OF OA CAN RESULT IN SIMILAR SKIN NECROSIS AT UNCOMMON ANATOMIC LOCATIONS CORRESPONDING TO THE SITE OF HA INJECTION. ALTHOUGH TISSUE NECROSIS IS A RARE COMPLICATION, PHYSICIANS NEED TO BE AWARE OF THIS POSSIBILITY AND SHOULD BE MINDFUL OF POTENTIAL TREATMENT OPTIONS TO MANAGE THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254613 HYALURONIC ACID (Y2) HYALURONIC ACID MOZ FIDIA FARMACEUTICI S.P.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other