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 Bacterial Infection (1735); Pain (1994); Swelling (2091); Weakness (2145); Toxicity (2333)

Event Date 11/11/2017

Event Type  malfunction  

Event Description

Based on additional information received on 05-dec- 2017, this case was upgraded to serious as an important medical event of device malfunction was added. This unsolicited case from united states was received on 05-dec-2017 from nurse. This case concerns a (b)(6) years old male patient who received treatment with synvisc one injection and after 1 day had increased weakness, swelling in both knees and sharp pains. Also device malfunction was identified for the reported lot number. No medical history, past drug, concomitant medication and concurrent condition was provided. On (b)(6) 2017, patient received treatment with intraarticular synvisc one bilateral injections, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020; indication: not provided). On (b)(6) 2017, patient called back reporting swelling in both knees, sharp pains, and increased weakness. Corrective treatment: not reported for all events. Outcome: unknown for all events. A global pharmaceutical technical complaint (ptc) was initiated with the global 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Additional information was received on 05-dec-2017 and 18-dec-2017 (both processed with the clock start date of 05-dec-2017). The case was upgraded to serious. Global ptc number and results were added. Additional event of device malfunction was added along with details. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment dated 5-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced lower extremities weakness, swelling of knees nd bilateral knee pain. 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: 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: 7163207
• MDR Text Key: 96616985
• Report Number: 2246315-2017-00562
• 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

• 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

• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/05/2017
• 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: 01/04/2018 Patient Sequence Number: 1