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); Swelling (2091)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Based on additional information received on 08-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 case was cross reference is (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from other non-health care professional.This case concerns a patient (age and gender unspecified) who received treatment with synvisc one and later after unknown latency had increased swelling.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (frequency, dose, indication and expiration date: not reported; lot number: 7rsl021) bilaterally.On an unknown date in (b)(6) 2017, unknown latency after receiving synvisc one injection, patient had increased swelling over the weekend but had improved by the third day.Corrective treatment: not reported for both events outcome: recovering for both events a pharmaceutical technical complaint (ptc) was initiated with (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: important medical event for device malfunction additional information was received on 08-dec-2017 and 08-jan-2018 (both processed together with the clock start date of 08-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.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 8-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee swelling.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: 7206098
• MDR Text Key: 98292281
• Report Number: 2246315-2018-00154
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: 12/08/2017
• 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