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 Problem Reaction, Injection Site (2442)

Event Type  malfunction  

Event Description

Based on additional information received on (b)(6) 2018, the case became valid and upgraded to serious as additional serious event of device malfunction (important medical event) was added.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional.This case concerns a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had reaction to synvisc one (unevaluable event).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 patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) bilateral injection (batch/lot number: 7rsl021; expiry date: may-2020).On an unknown date, after unknown latency the patient had reaction to synvisc one (unevaluable event).Action taken: unknown corrective treatment: not reported outcome: unknown for both a global 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)(6) 2018.The global ptc number with ptc results were added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from healthcare professional.The case became valid, additional event of device malfunction was added.Case upgraded to serious.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 12-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced reaction to the product.Although exact dates of suspect administration and event onset is not known, however, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product 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: 7368770
• MDR Text Key: 103571733
• Report Number: 2246315-2018-00409
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• 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: 03/12/2018
• 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