MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

Based on additional information received on 28-nov- 2017, this case initially processed as non-serious was upgraded to serious as serious event of device malfunction was added.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 28-nov-2017 from a non-healthcare professional.This case concerns a female patient of unknown age who received treatment with synvisc one and later on the same day had red knee, knee effusions, painful knee and swollen 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 patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020).On (b)(6) 2017, after unknown latency, the patient had knee effusions with red, swollen and painful knee.It was reported that the physician who administered synvisc one injection was highly experienced with technique.Action taken: unknown.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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction additional information was received on 28-nov-2017 and 16-dec-2017 (processed together with clock start date of 28-nov-2017).This case initially processed as non-serious was upgraded to serious as serious event of device malfunction was added with details.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 28-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced localized erythema, knee effusion, swollen knee and painful knee.A temporal relationship cannot be established with the product administration due ot lack of information regarding product start date.In addition, 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: 7150870
• MDR Text Key: 96241881
• Report Number: 2246315-2017-00532
• Device Sequence Number: 0
• Product Code: MOZ
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2017
• 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