MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR INJECTION

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Ambulation Difficulties (2544); Test Result (2695)

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Rdw low [red cell distribution width decreased].Mch high [mean cell hemoglobin increased].Rbc low [red blood cell count low].Wbc low [white blood cell count low].Limping gait [limping].Creatinine high 0.92 mg/dl [creatinine high].Glomerular filt.Rate low 58 ml/min/1.73m2 [glomerular filtration rate decreased].Inr low 0.94 na [inr decreased].Partial thromboplastin time decreased 21.9 seconds [activated partial thromboplastin time decreased].A/g ratio low [albumin globulin ratio decreased].Hdl cholesterol high [hdl cholesterol increased].Ldl high [decreased ldl].Vitamin b12 high [vitamin b12 increased].Left knee pain that has increased, pain with walking, tenderness at medial joint line, tenderness at lateral joint line, pain worsened by standing and walking, lower extremity pain, severe [knee pain] ([musculoskeletal pain]) swelling present [swelling of l knee].Weak flexion, "weqak" extension [stiff knees].Moderate joint effusion [joint effusion].Case narrative: this unsolicited case from united states was received on 10-may-2018 from a health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and a day later had moderate joint effusion; 5 days later patient experienced left knee pain that has increased, pain with walking, tenderness at medial joint line, tenderness at lateral joint line, pain worsened by standing and walking, lower extremity pain, severe, swelling present, weak flexion, "weqak" extension and limping gait; 6 days later had a/g ratio low , hdl cholesterol high , ldl high , vitamin b12 high, rdw low, mch high, rbc low, wbc low; after unknown latency developed, creatinine high 0.92 mg/dl, glomerular filt.Rate low 58 ml/min/1.73m2, inr low 0.94 na, partial thromboplastin time decreased 21.9 seconds.A device malfunction was noted in the reported lot number.No relevant past drugs, concomitant medications and concurrent condition were reported.Patient had history of back; cholecystectomy; colonoscopy; endoscopy; gallbladder; hysterectomy; lumbar laminectomy surgery and osteoarthritis (joint line tenderness and crepitus), arthritis; arthritis: knee; gastroparesis; hyperlipemia; hypertension; limb swelling; liver disease; lower back pain; lumbago/low back pain; lumbar disc herniation, l2-3; lumbar spinal stenosis; pain: bilateral knee; pre-op examination; rotator cuff tendinitis, right; spondylolisthesis, lumbar.Concomitant medications included altace; aspirin; atenolol; benadryl; biotin; calcium; domperidone; dyazide; fibercon; melatonin; "ramiprii"; sam-e; triamterene-"hydrochlorothiazid" 37.5-25 mg oral tablet; vitamin b-12; vitamin b-6.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at an unknown dose for left knee pain and primary osteoarthritis of left knee (lot number: 7rsl021).On an unknown date, after unknown latency, patient developed creatinine high 0.92 mg/dl, glomerular filt.Rate low 58 ml/min/1.73m2, inr low 0.94 na, partial thromboplastin time decreased 21.9 seconds.On (b)(6) 2017, a day after initiating treatment, patient was noticed to have left knee series demonstrating moderate to marked degenerative change with "chondrocaicinosis".On (b)(6) 2017, 5 days after initiating, patient developed experienced left knee pain that has increased, pain with walking, tenderness at medial joint line, tenderness at lateral joint line, pain worsened by standing and walking, lower extremity pain, severe, swelling present, weak flexion, "weqak" extension and limping gait.On (b)(6) 2017, 6 days after initiating treatment, patient developed a/g ratio low , hdl cholesterol high , ldl high , vitamin b12 high, rdw low, mch high, rbc low, wbc low.On (b)(6) 2017, patient recovered from weak flexion, "weqak" extension.Corrective treatment: walker, ice, hydrocodone bitartrate/paracetamol (norco), ketorolac tromethamine (toradol) for left knee pain that has increased, pain with walking, tenderness at medial joint line, tenderness at lateral joint line, pain worsened by standing and walking, lower extremity pain, severe; not reported for rest of the events.A product technical complaint was initiated on 16-may-2018 for synvisc one, batch number: 7rsl021, global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Outcome: recovered for weak flexion, "weqak" extension; unknown for rest of the events.Seriousness criteria: disability for left knee pain that has increased, pain with walking, tenderness at medial joint line, tenderness at lateral joint line, pain worsened by standing and walking, lower extremity pain, severe, device malfunction.Follow up as received on 16-may-2018.Global ptc number was added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8200892
• MDR Text Key: 131589744
• Report Number: 2246315-2018-00839
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/27/2018

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability