MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Bacterial Infection (1735)

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 12-dec-217 from physician this case concerns 5 patients who received treatment with synvisc one and after an unknown latency have had problems (unevaluable event).Also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown dates, patients received treatment with intra articular synvisc one injection (frequency, dose, indication and expiration date: not provided) with batch/ lot number: 7rsl021.On an unknown dates, latency unknown, patients had problems (unevaluable event).Action taken: unknown.Corrective treatment: not reported for device malfunction.Outcome: unknown for device malfunction.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 was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 19-dec-2017: this case concerns about multiple patients who experienced unspecified adverse events after receiving treatment with synvisc one injections from the recalled lot.Based on the available information, pharmacological plausibility cannot be established between the event and suspect product.However, further information regarding administration dates, event onset, latency, relevant medical history, past drugs, concomitant medication, concurrent clinical presentation and other risk factors is required for further case assessment.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7170820
• MDR Text Key: 97782788
• Report Number: 2246315-2017-00405
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• 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: 12/12/2017

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?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other