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

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Reaction (2414); Ambulation Difficulties (2544); Blood Loss (2597)

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 01-feb-2018 from patient this case concerns (b)(6) female patient who initiated treatment with synvisc one and after a few hours she got up and could not walk anymore/legs seized up/almost like she was paralyzed/could not walk/still cannot move right/could not move; after an unknown latency had an infection, excruciating pain/horrible pain of a level 10 on a 10 point scale, knees were enormously swollen and it went into lymph nodes up in my groin and arms/legs were twice the normal size, sores in her, inflamed bleeding gums, sores on her tongue, was still not well, rings on her arm that look like ringworm but do not respond to anti-fungal cream, pink nodules on the back of her arms, inflamed bleeding gums and knees were enormously swollen and it went into lymph nodes no medical history, previous medications, concomitant medications and concurrent conditions were reported.Patient had type 1 diabetes.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once bilateral knee oa (batch/ lot number: 7rsl021 and expiry date: unknown).On the same day, she got up and could not walk anymore.Her legs "seized up." it was almost like she was paralyzed.She could not walk for almost a week.Doctor told it was "just a normal reaction to synvisc-one".The doctor on call said it could be an infection, and with the holiday weekend, she went to the er on (b)(6) 2018, to get checked out.She was in excruciating pain and could not move.Her knees were "enormously swollen and it went into my lymph nodes up in my groin and arms.Her legs were twice the normal size.She had sores in her mouth, inflamed bleeding gums, sores on her tongue, and horrible pain of a level 10 on a 10 point scale.Fluid was drawn from the knee.She waited hours in the er and was told she did not have an infection.She still was not well.She had rings on her arm that look like ringworm but do not respond to anti-fungal cream.She has pink nodules on the back of her arms.She still has sores on her tongue.She says that she looks and feels terrible and still cannot move right.She had not been given any antibiotics or other medications to this point.Corrective treatment: antifungal cream for rings on her arm that look like ringworm but do not respond to antifungal cream; none for other events outcome: unknown for pink nodules on the back of her arms, inflamed bleeding gums, knees were enormously swollen and it went into lymph nodes, device malfunction, had an infection, excruciating pain/horrible pain of a level 10 on a 10 point scale, knees were enormously swollen and it went into lymph nodes up in my groin and arms/legs were twice the normal size, sores in her, inflamed bleeding gums, still not well; not recovered for others.Seriousness criteria: important medical event for device malfunction and had an infection 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.Pharmacovigilance comment: sanofi company comment dated 6-feb-18: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced joint infection, knee swelling and knee effusion.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products 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: 7272698
• MDR Text Key: 100469614
• Report Number: 2246315-2018-00306
• 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: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/01/2018

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/15/2018
• 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): Other