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); Reaction (2414)

Event Type  malfunction  

Event Description

Based on additional information received on 05-dec- 2017, this case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.This unsolicited case from united states was received on 05-dec-2017 from a healthcare professional (medical assistant).This case concerns 3 patients (demographics unspecified) who received treatment with synvisc one and later after unknown latency had pain and tenderness in the right knee and swelling in right knee.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 (dose, frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: 31-may-2020).On an unknown date, after unknown latency, patients experienced reactions to this synvisc-one's lot number action taken: unknown.Corrective treatment: not reported for both events.Outcome: unknown for both 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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction additional information was received on 05-dec-2017 and 18-dec-2017 (both information processed together with clock start date of 05-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of device malfunction was added with seriousness criterion as important medical event.Event of device malfunction was added along with its details.Global ptc number and ptc results were added.Clinical course was updated and 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 reactions.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: 7163201
• MDR Text Key: 96592322
• Report Number: 2246315-2017-00555
• 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: 12/05/2017

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?: No
• Device Operator: Other
• 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
• Date Manufacturer Received: 12/05/2017
• 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