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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

Based on the information received on (b)(6) 2018 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case is cross referred with the case (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2017 from physician.This case concerns a (b)(6) years old male patient who received treatment with synvisc one injection and on the same day had discomfort; after 5 days knee was very swollen/swelling; after unknown latency (120 degree) and extension (5 degree), genu varum deformity, had left knee warmth; after an unknown latency had increased pain/tenderness of the medial femoral condyle and the medial tibial plateau and difficulty ambulating.Also, device malfunction was identified for the reported lot number.No past drug and concurrent condition was provided.Concomitant medications included: acetylsalicylic acid (aspirin), biotin, clopidogrel, cyclobenzaprine hydrochloride (flexeril), morniflumate (flomax), krill oil, lisinopril, hydrochlorothiazide/metoprolol tartrate (lopressor hct), lorazepam, metoprolol tartrate, omeprazole, ingenol mebutate (picato), clopidogrel bisulfate (plavix), sertraline hydrochloride (sertraline), ezetimibe (zetia), cetirizine hydrochloride (zyrtec).Medical history included: heart disease, hypertensive disorder, osteoarthritis and arthritis on (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020) in left knee for osteoarthritis knee pain.On the same day, patient complained of discomfort.Nurse suggested rest, elevation, ice and compression.On (b)(6) 2017 after a latency of 5 days, patient's knee was very swollen.On (b)(6) 2018 inspection revealed that patient's left knee flexion was (120 degree) and extension was (5 degree).On the same day inspection revealed left knee warmth, swelling, and genu varum deformity.There was no tenderness of the medial patellar retinaculum or the patellar tendon.On an unknown date in 2017 after an unknown latency patient had increased pain, it was painful for him to walk and patient had difficulty ambulating.Corrective treatment: kenalog for flexion (120 degree) and extension (5 degree), genu varum deformity, left knee warmth; rest, ice packs, kenalog for knee very swollen/swelling, increased pain/tenderness of the medial femoral condyle and the medial tibial plateau; suggest rest, elevation, ice and compression for discomfort; not reported for difficulty ambulating.Outcome: unknown for all events.Seriousness criteria: required intervention for left knee warmth, increased pain/tenderness of the medial femoral condyle and the medial tibial plateau, knee very swollen/swelling, genu varum deformity, flexion (120 degree) and extension (5 degree) and device malfunction 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.Additional information was received on (b)(6) 2018.Events of knee very swollen/swelling, flexion (120 degree) and extension (5 degree), genu varum deformity, left knee warmth, increased pain/tenderness of the medial femoral condyle and the medial tibial plateau, difficulty ambulating and device malfunction were added.Medical history and concomitant medications were added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who suffered from joint range of motion decreased, genu varum, left knee swelling, left knee pain, joint warmth, discomfort in joints, and difficulty walking after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information except for the event of genu varum.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility of the events (except genu varum) to the product cannot be excluded.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7279339
• MDR Text Key: 100535595
• Report Number: 2246315-2018-00319
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2018
• 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): Required Intervention
• Patient Age: 75 YR