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 Problems Nausea (1970); Pain (1994); Swelling (2091); Weakness (2145); Dizziness (2194)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

Based on additional information received on 05-dec- 2017, this case initially considered non serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event.This unsolicited case from united states was received on 05-dec-2017 and 07-dec-2017 (processed together with clock start date as 5-dec-2017) from the consumer.This case concerns a female patient (age unspecified) who received treatment with synvisc one injection and after unknown latency the patient experienced difficulty putting weight on/ inability to bear weight, dizziness, nausea, weakness/ weakness with the knee, pain/ severe pain and swelling.Also device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection (lot number: 7rsl021 and expiration date: 31-may-2020; dose and frequency: not reported) in the single knee.On an unknown date, after unknown latency patient had swelling, pain, and difficulty putting weight on it.On an unknown date in 2017, unknown latency of receiving the injection the patient experienced severe pain, dizziness, weakness, nausea, and inability to bear weight on the injected knee.Patient had came back twice since the injection.Patient was last seen on (b)(6) 2017 in the office and was still complaining of severe pain and weakness with the knee.Corrective treatment: not reported for all.Outcome: not recovered for weakness/ weakness with the knee and pain/severe pain; unknown for rest.A global pharmaceutical technical complaint was initiated with 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: device malfunction: important medical event additional information was received on 05-dec-2017 and 18-dec-2017 (both processed together with the clock start date of 05-dec-2017).This case initially considered non serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event.The global ptc number with ptc result was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 5-dec-2017: this case concerns a patient who was received synvisc one injection from th recalled lot and later had weight bearing difficulty.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the casual relationship of the events to the product cannot be excluded.

• 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: 7164055
• MDR Text Key: 96707769
• Report Number: 2246315-2018-00013
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• 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