DUROLANE

Additional Manufacturer Narrative

PATIENT EXPERIENCED PAIN AND A RASH ON THE RIGHT KNEE FOLLOWING THE DUROLANE INJECTION. ONSET OF PAIN OCCURRED 24-36 HOURS AFTER THE INJECTION; DISCOLORATION BEGAN 2-3 DAYS POST-INJECTION. THE PRESCRIBING PHYSICIAN REFERRED THE PATIENT TO A DERMATOLOGIST FOR ASSESSMENT OF THE PATIENT'S POST INJECTION EXPERIENCE. THE DERMATOLOGIST (A SUBJECT MATTER EXPERT) DIAGNOSED THE CONDITION AS RETIFORM PURPURA AND A PATHOLOGY REPORT PROVIDED BY THE PRESCRIBING PHYSICIAN WAS INCONCLUSIVE FOR A DIAGNOSIS OTHER THAN TO CONFIRM THE PRESENCE OF "FOREIGN MATERIAL." AS SUCH, THE DIAGNOSIS FOR DETERMINING REPORTABILITY OF THE EVENT IS RETIFORM PURPURA. THE INVESTIGATION OF THE INVOLVED DUROLANE PRODUCTION LOT IS ONGOING. MEDICAL ASSESSMENT OF THE REPORTED EVENT IDENTIFIED RETIFORM PURPURA IS A SPECIFIC MORPHOLOGIC PATTERN OF SKIN BLEEDING WHICH APPEARS AS NET-LIKE AND PURPLISH. ITS CAUSE IS DAMAGE TO UNDERLYING BLOOD VESSELS (USUALLY OCCLUSION). IT HAS BEEN REPORTED AS AN ADVERSE EVENT ASSOCIATED WITH VISCOSUPPLEMENTATION. THE LENGTHY CLINICAL HISTORY OF COMMERCIAL HYALURONIC ACID USE HAS NOT, TO DATE, EXPOSED A SIGNIFICANT RISK FOR THIS EVENT FOLLOWING INTRAARTICULAR INJECTION. ALTHOUGH INTRAARTICULAR VISCOSUPPLEMENTATION IS INTENDED TO BE INJECTED INTO THE JOINT SPACE, NOT IN ANY SOFT TISSUE STRUCTURE, INADVERTENT DIRECT INJURY TO AND/OR INJECTION OF MATERIAL INTO THE UNDERLYING SKIN VESSELS HAS BEEN KNOWN TO OCCUR WITH VISCOSUPPLEMENTATION. THEREFORE, THE EVENT OF RETIFORM PURPURA SHORTLY AFTER THE DUROLANE INJECTION MAY HAVE BEEN CAUSED OR CONTRIBUTED TO BY THE DEVICE (DUROLANE). THE DUROLANE INSTRUCTIONS FOR USE (IFU) SPECIFIES INCIDENCES OF RASH AS POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH. THE DUROLANE IFU WARNINGS CITES "DO NOT INJECT-INTRAVASCULARLY, EXTRA-ARTICULARLY, OR IN THE SYNOVIAL TISSUES OR CAPSULES." NO INVESTIGATION IS REQUIRED TO EXPLORE AN ADDITIONAL CAUSAL RELATIONSHIP BETWEEN DUROLANE AND THIS PATIENT'S RETIFORM PURPURA.

Description of Event or Problem

PATIENT EXPERIENCED PAIN AND A RASH ON THE RIGHT KNEE FOLLOWING THE DUROLANE INJECTION. ONSET OF PAIN OCCURRED 24-36 HOURS AFTER THE INJECTION; DISCOLORATION BEGAN 2-3 DAYS POST-INJECTION.