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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 04-feb-2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate (batch: 7rsl021) and the batch was later recalled due to microbial contamination found in the batch and the patient experienced hypersensitivity, pain, swelling, could not sleep or move and had aspiration done.Patient also experienced having long-term sinus infections.As per the information available and temporal relation between the events and suspect, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Assumed that he had a hypersensitivity reaction to the product [hypersensitivity reaction], ([joint effusion], [knee swelling], [movements reduced], [device malfunction], [knee pain]).Long-term sinus infections [sinus infection].He could not sleep [sleep difficult].Case narrative: initial information from united states received on 27-jan-2021 regarding an unsolicited valid serious case received from the patient.This case involves an unknown age male patient who assumed that he had a hypersensitivity reaction to the product, long-term sinus infections and he could not sleep, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate injection (strength: 48 mg/6ml) at a dose of 18 mg once via unknown route (lot - 7rsl021; expiration date: unknown) for osteoarthritis.The mentioned batch was reported have been recalled due to device malfunction.Within 2 days of administration the patient experienced severe pain (arthralgia) and swelling (joint swelling) and it felt as if someone wrapped his knee in force (onset: (b)(6) 2017).Patient could not sleep (insomnia) or move around (hypokinesia) (onset: (b)(6) 2017).Patient went to his doctor for aspiration (joint effusion) (onset: (b)(6) 2017) of his knee which brought immediate relief.Patient assumed that he had had a hypersensitivity reaction to the product (hypersensitivity) (onset: 2017).Ever since receiving the product patient had long-term sinus infections (sinusitis) (onset: unknown).Patient was wondering if he might react to the covid vaccine and while searching discovered that the batch of hylan g-f 20, sodium hyaluronate received by him had been recalled.Patient asked for compensation of medical expenses.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for all events.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.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 11278099
• MDR Text Key: 230224750
• Report Number: 2246315-2021-00065
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/04/2021

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?: No
• Device Operator: No Information
• Device Lot Number: 7RSL021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2021
• 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): Other; Required Intervention