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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Arthralgia (2355); Joint Swelling (2356)

Event Type  malfunction  

Event Description

Device malfunction [device malfunction].Pain in one knee [knee pain].Swelling in one knee [knee swelling].Case narrative: initial information received from united states on 30-may-2018 regarding an unsolicited valid serious malfunction case received from the patient.This case involves an unknown age female patient who experienced pain and swelling in one knee unknown latency after she used medical device synvisc one; also, 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.On (b)(6) 2017, the patient started using intra-articular synvisc one injection dosage unknown (lot - 7rsl021) in both the knees for unknown indication.On an unknown date, the patient developed an event of a non-serious pain and swelling in one knee unknown latency after starting use of synvisc one.Patient went to the emergency room and was told that she did not had an infection and to treat symptoms by taking hot baths and icing the affected knee.Final diagnosis was swelling in one knee, pain in one knee and device malfunction.Action taken was unknown.It was reported the patient treat the symptoms by taking hot baths and icing the affected knee; not reported for device malfunction the patient outcome was reported as unknown for all the events.A pharmaceutical technical complaint was initiated on 06-jun-2018 for synvisc one with global ptc number: (b)(4).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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: medically significant for device malfunction follow up was received on 06-jun-2018.Global ptc number was added.

• 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: 7915447
• MDR Text Key: 123529986
• Report Number: 2246315-2018-00575
• 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: 09/26/2018

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?: No
• Device Operator: No Information
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2018
• 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