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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Device malfunction.Experienced allergic reactions (pseudosepsis).Aspirations of knee (knee effusion).Case narrative: this case was cross referenced with cases (b)(4) (cluster).Initial information received from united states on 29-nov-2018 regarding an unsolicited valid serious malfunction case received from a physician.This case involves adult (under (b)(6) years of age) male patient who experienced almost like a pseudo septic reaction (latency: same day), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).A device malfunction was noted in the reported batch number.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate dosage, intra-articular injection at an unknown dose (lot - 7rsl021) for unknown indication.On the same day (shortly after injection), patient had allergic reactions in the injection area, almost like a pseudo septic reaction.Patient had aspirations of knee (amounts unknown) and culture was negative.Patient was injected with steroid into the area.Patient recovered with no infection or complication.Final diagnosis was almost like a pseudo septic reaction and device malfunction.Corrective treatment: steroid and aspiration for almost like a pseudo septic reaction.Outcome: recovered for almost like a pseudo septic reaction.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.Additional information was received on 30-nov-2018.Global ptc number: (b)(4) was added.Text amended accordingly.

• 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: 8192957
• MDR Text Key: 131306291
• Report Number: 2246315-2018-00759
• 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
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2018
• 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
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention