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 Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 04-jan-2018 from the patient this case concerns a (b)(6) female patient who initiated treatment with synvisc one and after 1 day could not walk and after an unknown latency stayed in bed for three days, could not walk, likely a fever, swelling in knee and pain in knee, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.She was allergic to penicillin.She had also received synvisc one before.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown) and she experienced a reaction after the injection.On an unknown date in (b)(6) 2017, after an unknown latency, was in bed, got chills and fever.The next morning, she got up and could not walk.She reported that she stayed in bed for three days and missed a job interview due to this.She reported that after about three days of swelling and pain in the knee, she had to use a cane.She reported that she also experienced chills and likely a fever during those three days but she did not really take a temperature.Corrective treatment: not reported for all events.Outcome: recovered for stayed in bed for three days and recovering for others.Seriousness criteria: disability for stayed in bed for three days and device malfunction.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.Pharmacovigilance comment: sanofi company comment dated 10-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot and after that she had knee pain, swelling, couldn't walk and stayed in bed for three days.A temporal relationship can be established with the product administration.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.

Event Description

This spontaneous case from united states was received on 04-jan-2018 from the patient.This case concerns a (b)(6) years old female patient who initiated treatment with synvisc one and after 1 day could not walk and after an unknown latency stayed in bed for three days, could not walk, likely a fever, swelling in knee and pain in knee, also, device malfunction was identified for the reported lot number.Medical history included right knee replacement, high blood pressure.She was allergic to penicillin.She had also received synvisc one before.Concomitant medications included lisinopril for hypertension.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown) and she experienced a reaction after the injection.On an unknown date in (b)(6) 2017, after an unknown latency, was in bed, got chills and fever.The next morning, she got up and could not walk.She reported that she stayed in bed for three days and missed a job interview due to this.She reported that after about three days of swelling and pain in the knee, she had to use a cane.She reported that she also experienced chills and likely a fever during those three days but she did not really take a temperature corrective treatment: not reported for all events outcome: recovered for stayed in bed for three days and recovering for others seriousness criteria: disability for stayed in bed for three days and device malfunction 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented additional information was received on 10-jan-2018.Global ptc number was added.Additional information was received on 30-jan-2018 from patient.Concomitant medication, medical history and concurrent condition was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 30-jan-2018: follow up information did not change the previous case assessment.This case concerns a female patient who received synvisc one injection from the recalled lot and after that she had knee pain, swelling, couldn't walk and stayed in bed for three days.A temporal relationship can be established with the product administration.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
• MDR Report Key: 7209429
• MDR Text Key: 98294030
• Report Number: 2246315-2018-00128
• 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,Followup
• Report Date: 01/04/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Patient Sequence Number: 1
• Treatment: LISINOPRIL(CON.) - START; LISINOPRIL(CON.) - STOP UNKNOWN; PENICILLIN(PREV.); SYNVISC ONE (PREV.); SYNVISC ONE (PREV.)
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Weight: 82