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

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Based on additional information received on 05-dec- 2017, the case initially considered as non-serious was upgraded to serious as an important medical event of device malfunction was added.This case is cross referred with the case (b)(4).This unsolicited case from united states was received on 05-dec-2017 from nurse.This case concerns a (b)(6) years old male patient who received treatment with synvisc one injection and on the same day had pain, swelling and redness and after unknown latency had difficulty bearing weight.Also device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (batch/lot number: 7rsl021 and expiration date, indication, dose and frequency: not provided).On the same day, patient had pain, swelling and redness after receiving synvisc-one from the affected lot.On an unknown date in (b)(6) 2017, after unknown latency, patient had difficulty bearing weight.Also ice, elevation and compression were used as corrective treatment.Corrective treatment: ice, elevation and compression for difficulty bearing weight, pain, swelling and redness outcome: unknown for all events 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 05-dec-2017 and 15-dec-2017 (both the information were processed with the clock start date of 05-dec-2017) from an other non-health care professional.Patient's age was added.The case was upgraded to serious.Additional events of device malfunction and difficulty bearing weight were added along with details.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 25-dec-2017: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced to have pain, swelling, weight bearing difficulty and redness.Based on the available information, temporal relationship can be established between the events and the suspect product.However, as the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relation 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: 7163197
• MDR Text Key: 97728255
• Report Number: 2246315-2017-00491
• 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,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?: Yes
• Device Operator: Other
• 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
• Patient Age: 72 YR