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 Pain (1994); Swelling (2091); Toxicity (2333)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

Based on additional information received on (b)(4) 2017, this case initially considered as non-serious was upgraded to serious as an important medical event of device malfunction was added.This unsolicited case from united states was received on (b)(6) 2017 from a health care professional.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after 1 day had swelling, pain in knee and fluid was aspirated.Also device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On an unknown date in (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: 31-may-2020) in left knee for pain in knee.On an unknown date in (b)(6) 2017, 1 day after the injection, the patient returned back to the office with swelling and pain in her knee.Fluid was aspirated on the same day and was sent to the lab.Corrective treatment: knee aspirated for swelling and fluid aspirated for effusion (l) knee; not reported for pain in knee and device malfunction outcome: unknown for all events a pharmaceutical technical complaint (ptc) was initiated with 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.Seriousness criteria: important medical event for device malfunction additional information was received on (b)(4) 2017 and 12-jan-2018 (both the information was processed together with clock start date of (b)(4) 2017).The case was upgraded to serious.An additional event of device malfunction was added.Global ptc number and results were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated (b)(4) 2017: this case concerns a female patient who received synvisc one injection from the recalled lot and had left knee pain, swelling and fluid was aspirated.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: 7221101
• MDR Text Key: 98975384
• Report Number: 2246315-2018-00198
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/04/2017

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?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 01/26/2018
• 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: 61 YR