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

Lot Number 7RSL0201

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Fall (1848); Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 16-feb-2018 from a consumer (patient's husband).This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown latency knees became swollen, knees became painful, problems walking, two falls since the injections, continuing headaches, red spots around her body and sensations of biting around her body; after 13 weeks removed fluid from each knee.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.She had no history of falls prior to the injection.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 1 df once for osteoarthritis both knees (batch/lot number: 7rsl0201; expiry date: unknown) into both the knees.On an unknown date, after unknown latency, soon after the injections, both knees became swollen and painful.The left knee resolved after a couple days.The right knee stayed swollen and painful for many weeks.It was reported that the patient did not leave the house for three weeks.On an unknown date, the patient was said to have had two falls since the injections.She had no history of falls prior to the injection.On (b)(6) 2018, the patient's husband took her back to the clinic due to complications.During the visit, she was informed by the doctor she received injections from the recalled lot.The doctor was said to remove fluid from each knee.The patient got fluid removed from each knee (latency 13 weeks).The patient had taken no other medicines since receiving the injections.The patient was said to have had similar injections prior, with no complications.It was reported that the patient was said to still be in pain, and continued to have problems walking.On an unknown date, after unknown latency, the patient was having continuing headaches, and had red spots around her body.She continues to have sensations of "biting" around her body.The patient has no known food or drug allergies.The patient wants to be compensated for the two synvisc-one injections.It was unknown if the fluid removed was cultured.She has no other health problems aside from those sustained from the injections.Corrective treatment: not reported for all the events.Outcome: not recovered for all the events.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: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 16-feb-2018: this case concerns a female patient who had received synvisc-one injection from re-called lot and later developed knee swelling, pain, had walking difficulties and had knee effusion.The temporal relationship is significant and hence, causal role of suspect product cannot be ruled out in occurrence of the event.Furthermore, the concerned lot has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products 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: 7299441
• MDR Text Key: 101573027
• Report Number: 2246315-2018-00352
• 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: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/16/2018

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: Other
• Device Lot Number: 7RSL0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 02/27/2018
• 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
• Patient Age: 65 YR
• Patient Weight: 57