MAUDE Adverse Event Report: SANOFI GENZYME SYNVISC ONE, HYLAN G-F 20

Lot Number 7RSL021

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 11/28/2017

Event Type  Injury  

Event Description

Bi lateral injections of hylan (synvisc-one) in both knees as ongoing conservative treatment for end stage bone-on-bone osteoarthritis.Previous treatment includes physical therapy and intraarticular injections of steroids.Discussed with dr.This treatment vs.Steroids as a continuation of treatment before total knee replacement.Injections were performed.Noted to physicians assistant that felt pressure in right knee, but no pressure in left knee.Spent balance of day doing normal activities including walking.At approximately 8:00 pm, felt some stiffness in left knee.Went to bed.At 9:40 pm had to get out of bed due to pain.Right knee swollen, red, warm to touch and completely immobile with no weight bearing capability.Tried to walk to restroom and had to hop on left leg.By 11:00 pm was icing in effort to minimize swelling and pain.Tried additional pain medication with no success.Unable to bear weight in any position.Used crutches for mobility.Unable to rest or sleep.Called into work to notify that i would not be in.Called to dr.Office to discuss.Dr.Office reiterated that this was a known adverse effect.Continued with frequent ice therapy and pain medication, discussed again with dr.Office that this did not seem like a normal "adverse effect".Continued per dr.With ice therapy and tramadol prescription.Forty-eight hours post injection still no weight bearing capability.Knee was immobile with no flexibility, swollen, with pain extending upwards into thigh and down into calf.Continued conservation with dr.About adverse effects and noted to dr.That i did not agree that this was a typical adverse reaction.Seventy two hours post injection began showing improvements, though minimal.Remained on crutches for 7 days post injection.Flexibility and weight bearing ability have slowly returned.Currently 4 weeks post injection with left knee at par with pre-injection status.Right knee still not back to or better than pre-injection status.Strength: 6 ml millilitre(s).Quantity: other: 1 injection.Frequency: other: once.How was it taken or used: subcutaneous.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.Why was the person using the product: treatment was osteoarthritis.

• Brand Name: SYNVISC ONE, HYLAN G-F 20
• Type of Device: SYNVISC ONE, HYLAN G-F 20
• Manufacturer (Section D): SANOFI GENZYME
• MDR Report Key: 7154463
• MDR Text Key: 96205361
• Report Number: MW5074294
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Other Device ID Number: 58468-0090-3
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 145