Description of Event or Problem · 1
THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2014 VIA LITERATURE ARTICLE: WEINRAUCH P, TRIGGER R AND TSIKLEAS G. BILATERAL HIP JOINT HYLAN G-F 20 GRANULOMATOUS SYNOVITIS DUE TO VISCOSUPPLEMENTATION INJECTIONS. CASE REPORTS IN ORTHOPEDICS.2014. DOI.ORG/10.1155/2014/494073. THIS CASE INVOLVED A (B)(6) YEAR OLD MALE PT WHO DEVELOPED GRANULOMATOUS SYNOVITIS AFTER RECEIVING TREATMENT WITH SYNVISC IN HIP (OFF-LABEL USE). THE PT'S MEDICAL HISTORY WAS SIGNIFICANT BILATERAL HIP OSTEOARTHRITIS SECONDARY TO CAM TYPE FEMOROACETABULAR IMPINGEMENT, PARTICULARLY AFFECTING THE RIGHT HIP JOINT, SUBACROMIAL BURSITIS OF THE RIGHT SHOULDER TREATED BY ARTHROSCOPIC DECOMPRESSION, CENTRAL COMPARTMENT ARTHROSCOPIC DEBRIDEMENT FOR HIS RIGHT HIP. THE PAST DRUGS INCLUDED ANALGESICS NAD GLUCOSAMINE. NO CONCURRENT CONDITIONS AND CONCOMITANT MEDICATIONS WERE REPORTED. ON UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 02 ML (FREQUENCY, ROUTE, BATCH/LOT NUMBER AND EXPIRATION DATE: UNK) IN THE RIGHT HIP FOR HIP OSTEOARTHRITIS. ON AN UNK DATE, THE PT WAS RECOMMENDED FOR DEFINITIVE TREATMENT BY BIRMINGHAM HIP RESURFACING ARTHROPLASTY. IT WAS REPORTED THAT AT TIME OF SURGICAL INTERVENTION FOR HIS RIGHT HIP RESURFACING, MACROSCOPICALLY FLORID HYPERTROPHIC SYNOVITIS WAS SEEN SUBSTANTIALLY BEYOND THAT TYPICALLY SEEN WITH OSTEOARTHRITIC DEGENERATION. ON AN UNKNOWN DATE, BIOPSIES WERE TAKEN WHICH DEMONSTRATED HISTOLOGICAL EVIDENCE OF CHRONIC GRANULOMATOUS CHANGE. NO BACTERIA WERE IDENTIFIED ON GRAM STAIN AND NO CRYSTALS WERE DETECTED. CULTURES REMAINED NEGATIVE AND SPECIFIC STAINING AND HISTOLOGICAL EVALUATION CONDUCTED TO EVALUATE A CAUSE FOR THE GRANULOMATOUS SYNOVITIS FAILED TO IDENTIFY MYCOBACTERIA OR FUNGAL ELEMENTS. THE PATIENT'S RECOVERY AFTER HIS RESURFACING PROCEDURE WAS UNREMARKABLE, WITH A GOOD CLINICAL RESULT IN TERMS OF PAIN RELIEF AND FUNCTION. DESPITE THE FINDING OF FLORID SYNOVITIS WITHIN THE JOINT AT TIME OF ARTHROPLASTY, THE POSTSURGICAL RECOVERY APPEARED TO BE UNAFFECTED. THE PRECISE CAUSE FOR THE GRANULOMATOUS SYNOVITIS OBSERVED WITHIN THE HIP JOINT AT THIS STAGE WAS NOT DETERMINED BUT WAS FELT POSSIBLY TO BE DUE TO A REACTION SECONDARY TO THE ADIPOSE DERIVED STEM CELL THERAPY. TWELVE MONTHS AFTER HIS RIGHT HIP RESURFACING, THE PATIENT DESCRIBED INCREASINGLY PROBLEMATIC SYMPTOMS DUE TO LEFT HIP DEGENERATIVE JOINT DISEASE, INTERFERING WITH FUNCTION. X-RAYS DEMONSTRATED SIGNIFICANT ARTHRITIC CHANGE WITH RADIOGRAPHIC LOSS OF ARTICULAR JOINT SPACE. THE DECISION WAS MADE AT THIS TIME TO TREAT THE LEFT HIP BY A SINGLE HYLANG-F 20 VISCOSUPPLEMENTATION INJECTION (SYNVISC 2MLS). THE INITIAL RESPONSE AFTER THE INJECTION WAS UNREMARKABLE; HOWEVER, WITHIN SEVEN DAYS, THE PATIENT DESCRIBED INCREASING DISCOMFORT. THE SYMPTOMS AT THIS STAGE WERE CONSISTENT WITH ARTICULAR HIP IRRITATION; HOWEVER, HE REMAINED AMBULANT AND SYSTEMICALLY WELL WITHOUT SIGNS OF INFECTION. THE CLINICAL PICTURE WAS CONSISTENT WITH AN ACUTE LOCAL REACTIVE SYNOVITIS AND RECOMMENDATIONS MADE FOR CONTINUED OBSERVATION. ACCORDINGLY, THE ACUTE FEATURES SEEN ABOUT THE TIME OF INJECTION SETTLED; HOWEVER, ON THE BASIS OF CONTINUED CHRONIC JOINT IRRITABILITY AND SIGNIFICANT ARTHRITIS ON RADIOGRAPHIC GROUNDS; A DECISION WAS MADE TO PROCEED WITH A BIRMINGHAM HIP RESURFACING TWO MONTHS AFTER HIS LEFT HIP HYLAN INJECTION. AT TIME OF SURGICAL INTERVENTION, AGAIN MACROSCOPIC FLORID HYPERTROPHIC SYNOVITIS WAS OBSERVED. HISTOLOGY SPECIMENS UPON THE LEFT HIP SIMILARLY DEMONSTRATED CHRONIC SYNOVITIS WITH GRANULOMATOUS INFLAMMATION CONSISTENT WITH THOSE OBSERVED ON THE RIGHT HIP ONE YEAR PREVIOUSLY. CULTURE GROWTH REMAINED NEGATIVE AND NO CRYSTALS OR MYCOBACTERIAL OR FUNGAL ELEMENTS WERE IDENTIFIED. CLINICAL RECOVERY AFTER LEFT RESURFACING ARTHROPLASTY WAS ALSO UNREMARKABLE, WITH CLINICAL RESULTS APPARENTLY UNAFFECTED BY THE FINDING OF FLORID SYNOVITIS AT TIME OF SURGERY. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 02 ML (FREQUENCY, ROUTE, BATCH/LOT NUMBER AND EXPIRATION DATE: UNKNOWN) IN THE LEFT HIP FOR HIP OSTEOARTHRITIS. ON AN UNKNOWN DATE (WITHIN SEVEN DAYS), THE PATIENT EXPERIENCED INCREASING DISCOMFORT WITH SYMPTOMS OF ARTICULAR HIP IRRITATION. IT WAS REPORTED THAT THE PATIENT REMAINED AMBULANT AND SYSTEMICALLY WELL WITHOUT SIGNS OF INFECTION. THE CLINICAL PICTURE WAS CONSISTENT WITH AN ACUTE LOCAL REACTIVE SYNOVITIS AND PATIENT WAS RECOMMENDED FOR BIRMINGHAM HIP RESURFACING TWO MONTHS AFTER SYNVISC INJECTION. AT TIME OF SURGICAL INTERVENTION, AGAIN MACROSCOPIC FLORID HYPERTROPHIC SYNOVITIS WAS OBSERVED. HISTOLOGY SPECIMENS UPON THE LEFT HIP SIMILARLY DEMONSTRATED CHRONIC SYNOVITIS WITH GRANULOMATOUS INFLAMMATION CONSISTENT WITH THOSE OBSERVED ON THE RIGHT HIP ONE YEAR PREVIOUSLY. EVALUATION OF THE HISTOLOGICAL SPECIMENS REVEALED POTENTIAL ASSOCIATION WITH THE PREVIOUS CONDUCTED HYLAN INJECTIONS. ALCIAN BLUE STAIN DEMONSTRATED HYLAN MATERIAL CENTRALLY LOCATED WITHIN THE GRANULOMAS WITH EVIDENCE OF PREDIGESTION OF THE MATERIAL WHEN TREATED WITH HYALURONIDASE. ON THE BASIS OF THESE FINDINGS, TOGETHER WITH THE CLINICAL HISTORY AND MACROSCOPIC APPEARANCE AT TIME OF SURGERY IN BOTH HIPS, THE DIAGNOSIS OF CHRONIC GRANULOMATOUS INFLAMMATION, SECONDARY TO HYLAN G-F-20 (SYNVISC) INJECTIONS, WAS DIAGNOSED. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED OUTCOME: UNKNOWN A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT FOR BOTH THE EVENTS. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2014: IN THIS CASE, THE CAUSAL ROLE OF SYNVISC CANNOT BE EXCLUDED FOR THE OCCURRENCE OF GRANULOMATOUS SYNOVITIS, HOWEVER, THE LACK OF INFORMATION REGARDING THE UNDERLYING MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS USED BY THE PATIENT PRECLUDES THE COMPLETE CASE ASSESSMENT.