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 Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 15-dec-2017 from a non-healthcare professional. This case concerns a (b)(6) male patient who received treatment with synvisc one and experienced redness, significant pain, swelling, warmth to both knees with the right knee being the worst knee (latency: 0 day); was having issues with walking/cannot walk (latency: unknown); also, device malfunction was identified for the reported lot number. The patient had osteoarthritis (oa) in bilateral knees. The patient had been getting the synvisc products since 2008. The patient reported no other preexisting health issues. On (b)(6) 2016, the patient received a synvisc one injection with batch/lot number: 6rsl037a; expiration date: aug-2019. The patient also received an injection on (b)(6) 2016. The concomitant medication was xylocaine for numbing the knee preinjection. No other medical history or concurrent condition was reported. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021) into bilateral knees for oa bilateral knees. It was reported that the doctor did use xylocaine for numbing the knee pre-injection but the reporter was not sure what prep was used to perform the sterile injections. The same day, after about one hour post injection, the patient experienced significant pain, swelling, redness and warmth to both knees with the right knee being the worst knee. On an unknown date in (b)(6) 2017, after unknown latency, the patient was having issues with walking. The patient went to the emergency department (ed) on (b)(6) 2017 for treatment as patient was having pain in both knees, could not walk or bend either knee. In the ed, they performed bloodwork, x-rays and ultrasound and also sent fluid for cultures. It was not known how much fluid was taken from the knees. It was reported that the cultures were pending and the patient was being seen today ((b)(6) 2017) and taking pain medications for the pain in the knees. The patient was not prescribed antibiotics until the test results came back. As of (b)(6) 2017, the patient was still in pain and was seen by the doctor that day and this was not resolved. Corrective treatment: unspecified medication for significant pain; not reported for rest of the events. Outcome: not recovered for significant pain; unknown for rest of 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 criterion: important medical event (ime) for device malfunction pharmacovigilance comment: sanofi company comment dated 23-dec-2017: this case concerns a patient who suffered from localized erythema, knee swelling, knee pain, joint warmth and walking problems after receiving synvisc one injection from the recalled lot. Temporal relationship can be established between the events and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company, therefore, the pharmacological plausibility 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: 7185261
• MDR Text Key: 98009833
• Report Number: 2246315-2017-00516
• 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

• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• 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
• Event Location: No Information
• Date Manufacturer Received: 12/15/2017
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/12/2018 Patient Sequence Number: 1