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

Lot Number 7RSL021, 7RSL019

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Arthritis (1723); Bacterial Infection (1735); Pain (1994)

Event Date 11/29/2017

Event Type  malfunction  

Event Description

(b)(4) this spontaneous case from united states was received on 08-dec-2017 from nurse.This case concerns a (b)(6) male patient who initiated treatment with synvisc one and after 2 days had 100 degree temp, stomach issues and excessive soreness, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for right knee arthritis (batch number: 7rsl021; expiry date: unknown).On (b)(6) 2017, after a latency of 2 days, patient was complaining of excessive soreness; he also said that he had a 100 degree temp with stomach issues.Corrective treatment: not reported for all events.Outcome: not recovered for all events.Seriousness criteria: important medical event for 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 08-jan-2017: this case concerns a male patient who received synvisc one injection from the recalled lot for left knee arthritis and later experienced excessive soreness, stomach issues and 100 degree temperatuure.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 case was cross referenced with cases: (b)(4).This spontaneous case from united states was received on (b)(6) 2017 from nurse.This case concerns a 77 years old male patient who initiated treatment with synvisc one and after 2 days had 100 degree temp, stomach issues and excessive soreness/ increased soreness, also, device malfunction was identified for the reported lot number.No concurrent conditions were reported.Concomitant medications included metformin hydrochloride (metformin), metoprolol tartrate (metoprolol), simvastatin, valsartan/hydrochlorothiazide (valsartan/ hctz).Patient had penicillin allergy.Patient had a medical history of diabetes, and hypertension.On 27-nov-2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for right knee arthritis and osteoarthritis (batch number: 7rsl021; expiry date: unknown).On the same day, the patient received treatment with intra articular synvisc one injection at a dose of 6 ml once for right knee arthritis (batch number: 7rsl019; expiry date: 01-may-2020).On (b)(6) 2017, after a latency of 2 days, patient was complaining of excessive soreness and increased soreness; he also said that he had a 100 degree temp with stomach issues.On (b)(6) 2018, the patient left message for follow-up.On (b)(6) 2018, the patient returned for follow up with no issues.Corrective treatment: rest , ice, nsaids for excessive soreness/ increased soreness; not reported for all events outcome: recovered for excessive soreness/ increased soreness; not recovered for all 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction follow up information was received on 17-jan-2018.Global ptc number was added.Text was amended accordingly.Additional information was received on 09-apr-2018 from healthcare professional.Regimen of synvisc one was added.Osteoarthritis was added as indication for synvisc one.Verbatim of event excessive soreness was updated to excessive soreness/ increased soreness.Outcome of the event was updated from not recovered to recovered.Corrective treatment of excessive soreness/ increased soreness was added.Concomitant medications, penicillin allergy and medical history were added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 08-jan-2017: this case concerns a male patient who received synvisc one injection from the recalled lot for left knee arthritis and later experienced excessive soreness, stomach issues and 100 degree temperatuure.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: 7178473
• MDR Text Key: 97861512
• Report Number: 2246315-2018-00086
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021, 7RSL019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Patient Sequence Number: 1
• Treatment: METFORMIN(CON.); METOPROLOL(CON.); PENICILLIN(PREV.); SIMVASTATIN(CON.); VALSARTAN/HYDROCHLOROTHIAZIDE(CON.)
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 104