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 Swelling (2091); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  malfunction  

Event Description

Based on additional information received on 22-nov- 2017, this case initially considered non serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 10-nov-2017 from a healthcare professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after unknown latency was unable to put weight, unable to walk, had severe swelling and large effusion.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 once at a dose of 6 ml (batch/lot number: 7rsl021 and expiration date: 31-may-2020).On an unknown date, after unknown latency, the patient had severe swelling, were unable to put weight or walk on their injected knee.On an unknown date, after unknown latency, the patient had large effusion.It was reported that the patient was treated conservatively, and advised to take it easy this weekend.It was reported that the patient was advised if they still have a large effusion next week, it might possibly need to be drained.Since an unknown date, device malfunction was identified for the reported lot number.Corrective treatment: unspecified for unable to put weight, severe swelling and unable to walk; not reported for large effusion.Outcome: not recovered for all the events.A pharmaceutical technical complaint (ptc) was initiated with 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 22-nov-2017.This case initially considered non serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event.The global ptc number with ptc results was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced weight bearing difficulty, unable to walk, left knee swelling and knee effusion.A temporal relationship cannot be established with the product administration since event onset date and product therapy details are unknown.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: 7138161
• MDR Text Key: 96240491
• Report Number: 2246315-2017-00300
• Device Sequence Number: 0
• Product Code: MOZ
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 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
• Patient Age: 74 YR