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 Swelling (2091); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Type  malfunction  

Event Description

Based on the information received on 22-nov-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional (medical assistant).This case concerns 7 patients of unknown demographics who received treatment with synvisc one and later after unknown latency had difficulty walking, inability to bear weight on the knee, knee is hot and warm to touch and swelling, also, device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patients initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021; expiry date: unknown).On an unknown date, after unknown latency, the patients had difficulty walking, inability to bear weight on the knee, knee was hot and warm to touch and swelling.It was reported that doctor did not feel comfortable using the rest of the syringes as they were all from lot 7rsl021 and office would like them replaced.Corrective treatment: not reported for all the events outcome: unknown for all the 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 22-nov-2017 and 12-jan-2018 (processed with clock start date of 22-nov- 2017).Global ptc number and ptc results were added.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated (b)(6) 2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced difficulty walking and weight bearing difficulty.A temporal relationship cannot be established with the product administration as the exact dates has not been provided.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: 7221044
• MDR Text Key: 98887424
• Report Number: 2246315-2018-00196
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• 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