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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Type  malfunction  

Event Description

Synvisc one injection from recalled lot [device malfunction].Pain/hurt [pain].Swelling [swelling].Feels like a real cripple/trying to walk without tripping/ difficulty in taking steps [walking difficulty].Stiffness [stiffness].Case narrative: this case is related to case ids.: (b)(4)(cluster cases).Initial information received on 27-jul-2018 regarding an unsolicited valid serious malfunction case received from united states via a non-healthcare professional through social media.This case involves adult patient who experienced synvisc one injection from recalled lot, pain/hurt, swelling, feels like a real cripple/trying to walk without tripping/ difficulty in taking steps and stiffness while he/she using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown) the patient had history of administration of synvisc one.The patient past medical history, vaccination(s) and family history were not provided.On an unknown date, the patient started using synvisc one dosage unknown (lot - 7rsl021) via intra-articular route for product used for unknown indication.On unknown date, the patient received injection synvisc one injection from recalled lot.The patient experienced pain/hurt and swelling after receiving injection from the recalled lot.Patient reported that feels like a real cripple/trying to walk without tripping/ difficulty in taking steps and stiffness.Patient took pills for the treatment for pain/hurt.No further information provided.Final diagnosis was swelling, pain/hurt, synvisc one injection from recalled lot, feels like a real cripple/trying to walk without tripping/ difficulty in taking steps and stiffness.Corrective treatment: not reported for the all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for synvisc one injection from recalled lot.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.Follow up information was received on 22-aug-2018.No new information was received.

• 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: 7946640
• MDR Text Key: 124980738
• Report Number: 2246315-2018-00668
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/09/2018

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: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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