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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Erythema (1840); Fatigue (1849); Fever (1858); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 22-dec-2017 from a consumer (patient's wife). This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had fever, pain/pain in knee, swelling in knee and fluid in knee. Also device malfunction was identified for the reported lot number. No past drug, concomitant medication or concurrent condition was provided. The medical history included diabetes type ii. He had no known allergies. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the left knee. On an unknown date in (b)(6) 2017, soon after receiving the injection, the patient experienced pain and swelling in the knee. The patient was taking hydrocodone bitartrate/ paracetamol (norco) for pain, as well as meloxicam. He was also said to take over the counter medications for pain. On an unknown date in (b)(6) 2017, the patient experienced a fever. His physician was currently in the process of scheduling the patient for aspiration of the affected knee. No lab work had been performed to date. The patient was not hospitalized, and had not seen his physician to date. It was reported that the patient had not been prescribed antibiotics. He had needed a cane for ambulation since the symptoms began. His symptoms were still present, but his fever had resolved corrective treatment: cane for ambulation for swelling in knee; hydrocodone bitartrate/paracetamol (norco), meloxicam, over the counter medications, cane for ambulation for pain/pain in knee; not reported for rest of the events outcome: recovered for fever and not recovered 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 criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 28-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced fever, pain, fluid and swelling in knee. 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 causal relationship of the events to the products cannot be excluded.

• 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 ; 9089817289
• MDR Report Key: 7182468
• MDR Text Key: 97984483
• Report Number: 2246315-2017-00577
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/22/2017
• 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?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/11/2018 Patient Sequence Number: 1