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 Synovitis (2094); Toxicity (2333); Reaction (2414)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This case is cross referenced with case: (b)(4), (cluster).This unsolicited case from united states was received on 22-dec-2017 from a healthcare professional.This case concerns an adult male patient who received treatment with synvisc one and after unknown latency the patient experienced adverse reaction (unevaluable event).Also, device malfunction was identified for the reported lot number.No past drug, concomitant medication, medical history or concurrent condition was provided.On an unknown date, the patient initiated treatment with single intra-articular synvisc one injection, (dose, frequency, indication and expiration date: unknown) (batch/lot number: 7rsl021).On an unknown date, latency unknown, the patient experienced adverse reaction (unevaluable event) action taken: unknown.Corrective treatment: not reported for both events.Outcome: unknown for both 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 22-dec-2017: this case concerns a male patient who received synvisc one injection from the recalled lot and experienced adverse reaction.As the concerned lot number has been identified to have malfunction by the company, the causal relationship of suspect product cannot be ruled out with the occurrence of adverse events.

Event Description

This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 22-dec-2017 from a healthcare professional.This case concerns a (b)(6) year old male patient who received treatment with synvisc one and after unknown latency the patient experienced synovitis/inflammation.Also, device malfunction was identified for the reported lot number.No past drug, concomitant medication, medical history or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021; expiry date: 31-may-2020) for primary osteoarthritis.The same day, few hours after injection, the patient had increased knee pain and swelling.On (b)(6) 2017, aspiration of right knee was done and final cultures were with no growth (aerobic & anaerobic).On (b)(6) 2018, right knee mri was done which showed advanced degenerative joint disease mostly involving medial compartment (without effusion) with associated medial meniscus tear that was degenerative in nature.On an unknown date, after unknown latency, the patient had synovitis/inflammation mild.The patient was placed on a short course of prednisone.The final joint cultures of (b)(6) 2018 showed no growth.On (b)(6) 2018, the patient was recommended physical therapy.It was reported that the patient was doing better.Corrective treatment: prednisone for synovitis.Outcome: recovering for both 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: required intervention for synovitis/inflammation and device malfunction additional information was received on 31-jan-2018 from the healthcare professional.The previously reported event of "adverse reaction" was deleted.Additional event of synovitis was added with details.The symptoms of experienced adverse reaction/increased knee pain, inflammation and swelling were added.The suspect product dose, frequency, expiration date and indication were added.The seriousness criteria for the event of device malfunction was updated from important medical event to required intervention.Action taken updated from unknown to not applicable.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 31-jan-2018: this case concerns a male patient who received synvisc one injection from the recalled lot and experienced adverse reaction of synovitis.As the concerned lot number has been identified to have malfunction by the company, the causal relationship of suspect product cannot be ruled out with the occurrence of adverse events.

• 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: 7192827
• MDR Text Key: 98183688
• Report Number: 2246315-2017-00584
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR