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); Discomfort (2330); Reaction, Injection Site (2442)

Event Date 01/26/2018

Event Type  malfunction  

Event Description

Based on the information received on 13-mar-2018 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case was cross referred with: (b)(4) (cluster).This spontaneous case from united states was received on 26-jan-2018 from other non health care professional this case concerns a female patient (age unknown) who initiated treatment with synvisc one and after an unknown latency had some swelling and discomfort.Also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection (batch/lot number: 7rsl021; expiry date: unknown) (indication, frequency, dose: unknown).On an unknown date after an unknown latency had some swelling and discomfort.Action taken: unknown.Corrective treatment: not reported for all events.Outcome: unknown for all events.A product technical complaint 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 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 13-mar-2018.Additional event of device malfunction was added.Global ptc number and ptc results were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 21-mar-2018: this case concerns a patient who had received synvisc-one injection from re-called lot and later developed swelling and discomfort.The temporal relationship is significant and hence, causal role of suspect product cannot be ruled out in occurrence of the event.Furthermore, the concerned lot 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: 7380921
• MDR Text Key: 104154971
• Report Number: 2246315-2018-00416
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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: 03/13/2018
• 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