MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Event Description

Synovitis both knees [synovitis] ([condition aggravated], [stiffness], [exercise capacity decreased], [knee pain]); device malfunction [device malfunction]; lumbar degenerative disc syndrome [lumbar disc disease] ([leg pain], [back pain], [radicular pain]); pain in my hip/bilateral gluteal pain [pain in hip].Case narrative: initial information received on (b)(6) 2018 from united states regarding an unsolicited valid serious case received from a physician.This case involves a (b)(6) female patient who experienced synovitis both knees, device malfunction and lumbar degenerative disc syndrome, after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included fall on (b)(6) 2017 which resulted in a scaphoid fracture and thumb mp joint volar plate laxity.The patient stated that she was walking down some steps and fell onto the concrete which resulted in back pain and left wrist pain and urinary incontinence added.The patient reported that she underwent arthroscopy in 2010.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2017, the patient received intra-articular injection of synvisc one (hylan g-f 20, sodium hyaluronate) at dosage of 6 ml 1x (lot - 7rsl021, may 2020) for osteoarthritis.Both the knees patella tendon portals were sterilized with betadine and alcohol and 5ml of 1% xylocaine followed by synvisc-one was injected.The patient tolerated the procedure well and the site was cleaned was cleaned with alcohol and a band-aid was applied.On (b)(6) 2017, patient reported to the clinic for a check-up regarding her scaphoid fracture and thumb mp joint volar plate laxity which she had as a result of falling down the stairs on (b)(6) 2017.She was reported to be doing better.On (b)(6) 2017, patient reported to the clinic with complains of more pain than expected after the synvisc one injection.She further stated that she had stiffness at the end of the day and the patient was diagnosed with synovitis both knees (latency: 16 days) post synvisc-one injection.The patient was given bilateral cortisone injections after conducting her physical examination.Both the knees were sterilized using betadine and alcohol and 5ml lidocaine and 0.5ml kenalog was injected and a band-aid was applied.The patient also reported that she had difficulty exercising since the past few months.Further she stated that she had lost over 100 pounds as well.On (b)(6) 2018, patient reported to the clinic with complaints of pain, stiffness in wrist and muscle weakness due to the scaphoid fracture and volar plate injury she had 3 months ago.The patient was advised to undergo an occupational therapy in conjunction with a home exercise program.On (b)(6) 2018, patient reported to the clinic with complaints of radicular leg pain, pain in my hip/bilateral gluteal pain and midline back pain from lower thoracic region to lower lumbar region and was diagnosed with lumbar degenerative disc syndrome (latency: 6 months 29 days).The patient was given norco, flexeril and celebrex as corrective treatment for the same.Corrective treatment: methylprednisolone (medrol dosepak), triamcinolone acetonide (kenalog [triamcinolone acetonide]) and lidocaine (lidocaine) for synovitis; cortisone (cortisone) for synovitis, for synovitis, celecoxib (celebrex), cefixime (flexeril [cefixime]), hydrocodone bitartrate, paracetamol (norco) for intervertebral disc disorder seriousness criterion: required intervention for synovitis both knees, device malfunction outcome: unknown for all events a product technical complaint (ptc) was initiated on 17-aug-2018 for synvisc one.Batch number; 7rsl021, local ptc number: (b)(4), global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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.Follow up information received on 17-aug-2018.No new information received.Follow up information was received on 27-aug-2018.Global ptc number was added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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: 7947250
• MDR Text Key: 123196049
• Report Number: 2246315-2018-00661
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention