MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC-ONE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number UNAVAILABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Vomiting (2144); Weakness (2145); Dizziness (2194); Viral Infection (2248); Cognitive Changes (2551); Hyponatremia (4494); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/15/2012

Event Type  Injury  

Event Description

Patient is a previously healthy (b)(6) year old white, married woman who received an intra-articular injection of synvisc-one in the left knee on (b)(6) 2012.She presented to a local ed on (b)(6) 2012 complaining of left knee swelling and pain, along with abdominal pain, nausea, vomiting, weakness, and dizziness which began around (b)(6).She also noticed some "bumps" on her back at the base of her neck on (b)(6).In ed, patient's vital signs were stable and unremarkable.Her left knee was swollen, tender, and non-erythematous.Range of motion was reduced because of pain and swelling.She was neurovascularly intact distal to the left knee.Three non-pruritic papulonodular lesions were present at base of neck.Patient was alert and oriented to person, place, time, and situation.Radiographs of the left knee revealed a large joint effusion.She had leukocytosis, hyponatremia, and an elevated westergren erythrocyte sedimentation rate and c-reactive protein.Urinalysis suggested infection and was sent for culture.Ortho was consulted and septic arthritis of left knee was suspected; the patient was admitted.Left knee was aspirated-joint fluid analysis was unremarkable-and a sample was sent for culture.Arthroscopy was performed on the evening of (b)(6) with irrigation, debridement and extensive synovectomy.Cefazolin 1 gm iv q8 hours started prior to procedure.It was noted on (b)(6) that the patient had altered mental status-she was very drowsy and unable to carry on a clear conversation.The patient's hyponatremia was treated with iv normal saline.White blood cell count was still elevated but trending downward.One of the nodular lesions on the patient's upper back was punctured and a sample of the fluid was sent for culture.Another urinalysis suggestive of infection and was sent for culture.It was again noted on (b)(6) that the patient's mental status was altered.She tended to repeat herself and would stop speaking mid-sentence.The left knee was only slightly swollen with no erythema, but was still painful and patient was unable to bear any weight on it.More skin nodules were identified above the left knee.White count continued to decline, but was still elevated.Sodium remained low.Initial results of synovial fluid culture came back on (b)(6).Gram stain showed moderate neutrophils (6-30/hpf) but no organisms.Two blood samples were obtained and sent for culture.Two more urinalyses were performed and samples sent for culture.The urinalyses were both negative.The two prior urine cultures showed no growth to date.The antibiotic was changed from cefazolin to ceftaroline 600mg iv q12 hours on (b)(6).Patient was still confused on (b)(6), continuing repetitive speech and blocking.She also complained of some abdominal pain and nausea.Range of motion in left knee had improved, but was still reduced to about 150 degrees of flexion.Skin nodules continued to appear and now were present on her back, left knee, left arm, right temple, and right upper chest (12-15 in total).Two of these nodules were biopsied.All previously obtained cultures remained negative to date (joint fluid, urine, blood, and skin nodule cultures).Another culture was taken from a skin nodule on the patient's right temple.On (b)(6), the patient was much less confused, but still displayed some repetitive speech and blocking.She noted a painful lesion on the inside of her upper lip.She also complained of redness, swelling, and pain in the left wrist.There was swelling and bruising on the posterior left knee and edema in both legs.Range of motion of left knee reduced at around 140 degrees of flexion.All cultures remained negative.The skin biopsies showed palisaded neutrophilic and granulomatous dermatitis.Herpes viral antigen tested from ulcer on lip.White count continued a downward trend, and sodium began correcting on its own.She was given 125mg of methylprednisolone iv.Patient was no longer confused on (b)(6).Abdominal pain and nausea were gone.Swelling in left knee had dissipated.Left wrist swelling and pain had decreased.In addition, the skin nodules had begun to improve.Patient began to tolerate diet and to ambulate on her own.Patient received another dose of 125mg methylprednisolone iv.Patient received 120mg of prednisone on (b)(6), and again on (b)(6).The patient continued to improve and was discharged to home on (b)(6) 2012.Hylan g-f 20.

• Brand Name: SYNVISC-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION ; ridgefield NJ
• MDR Report Key: 10844158
• MDR Text Key: 216666986
• Report Number: MW5097905
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Weight: 73