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 01/01/2020

Event Type  Injury  

Event Description

Hypersensitivity reaction [hypersensitivity reaction] ([device malfunction]).Case narrative: the case is linked to: (b)(4) (multiple devices for same patient).Initial information received from united states on 15-jun-2020 and 18-jun-2020 regarding an unsolicited valid serious malfunction case received from other health professional.This case involves a (b)(6) female patient who had hypersensitivity reaction, after treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was identified for the reported lot number.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.After the treatment with hylan g-f 20, sodium hyaluronate in (b)(6) 2017, patient planned on getting the treatment again and ordered the product from pharmacy which was sent directly to her.She changed her mind and did not receive it at that time.Then in (b)(6) 2020 she decided that since she had already paid for it she might as well get it injected.In (b)(6) 2020 (6 weeks before (b)(6) 2020), the patient had treatment with hylan g-f 20, sodium hyaluronate at the dose of 48 mg, once via unknown route (lot - 7rsl021, expiration date: 31-may-2020) for oa (osteoarthritis) in the knee (unclarified which knee) by the healthcare professional.On an unknown date in 2020, after unknown latency, patient had hypersensitivity reaction.Event was assessed as medically significant.When patient realized that she had received a injection of the recalled lot, she felt that was the reason for the reason and was now threatening legal action toward her healthcare professional.Action taken: not applicable.It was not reported if the patient received a corrective treatment.Outcome: unknown.A product technical complaint (ptc) was initiated on 16-jun-2020 for synvisc one with lot number: 7rsl021 and global ptc number: (b)(4).Investigation was initiated for increase number of reported aes (adverse events).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.An investigation ((b)(4)) was performed and capas were identified with timelines for implementation of these capas.Investigation complete date: 18-jun-2020.

• 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: 10185098
• MDR Text Key: 201160319
• Report Number: 2246315-2020-00073
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/22/2020

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: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2020
• 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): Other; Required Intervention