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 Pain (1994); Swelling (2091); Neck Stiffness (2434); Ambulation Difficulties (2544)

Event Date 12/15/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 30-jan-2018 from patient.This case concerns female patient who initiated treatment with synvisc one and after a few hours had swelling in the affected knee and had intense pain/ painful to the point of tears; on the same day was unable to climb the stairs, use her husband's crutches to help her walk, could feel the leg swell, had ankle swelled and stiffness in her knee/knee becoming stiff.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 (indication, frequency and dose: unknown; batch/ lot number: 7rsl021 and expiry date: unknown).On the same day, after a few hours, stated that she knew something was wrong the evening of the injection because she began to experience intense pain and swelling in the affected knee.Caller states that she had to sleep in a chair because she was unable to climb the stairs and had to use her husband's crutches to help her walk.Caller states that she has been able to sleep in her bed for the last 10 days but can only sleep for a few hours due to the pain and stiffness in her knee.Caller stated that she can sit and walk now but only for short periods of time due to the knee becoming stiff and painful to the point of tears.Caller stated that she called her doctor the day after the injection but has not been back since to receive follow up or testing.Corrective treatment: crutches for use her husband's crutches to help her walk; sleep in a recliner for can only sleep for a few hours due to the pain; icing and elevating her leg for could feel the leg swell, swelling in the affected knee; icing for ankle swelled, intense pain/painful to the point of tears and stiffness in her knee/knee becoming stiff; not reported for unable to climb the stairs.Outcome: unknown for all events.Seriousness criteria: disability for device malfunction and unable to climb the stairs.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 5-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had difficulty in walking for which patient used crutches.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 (b)(6) 2018 from patient.This case concerns female patient who initiated treatment with synvisc one and after a few hours had swelling in the affected knee and had intense pain/ painful to the point of tears; on the same day was unable to climb the stairs/could not stand or walk or sit for any length time without pain, use her husband's crutches to help her walk/walking with a limp/could not stand or walk or sit for any length time without pain, could feel the leg swell//could feel knee and calf swelling/swelling included full leg and ankle, had ankle swelled/swelling included full leg and ankle and stiffness in her knee/knee becoming stiff, discomfort in my knee much of the time, could not sleep for more than 1 or 2 hours after unknown latency.No concurrent conditions were reported.Patient had a medical history of arthritis.Patient had caffeine, anesthesia, sublimaze, epinephrine.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (indication, frequency and dose: unknown; batch/ lot number: 7rsl021 and expiry date: unknown) for lubrication (joint lubrication).On the same day, after a few hours, stated that she knew something was wrong the evening of the injection because she began to experience intense pain and swelling in the affected knee.Caller states that she had to sleep in a chair because she was unable to climb the stairs and had to use her husband's crutches to help her walk.Caller states that she has been able to sleep in her bed for the last 10 days but can only sleep for a few hours due to the pain and stiffness in her knee.Caller stated that she can sit and walk now but only for short periods of time due to the knee becoming stiff and painful to the point of tears.Caller stated that she called her doctor the day after the injection but has not been back since to receive follow up or testing.On (b)(6) 2018, the knee x-ray revealed that knee damage.On (b)(6) 2018, the patient had blood test and it revealed that no bacteria was remaining.Corrective treatment: crutches for use her husband's crutches to help her walk/walking with a limp/could not stand or walk or sit for any length time without pain; sleep in a recliner for can only sleep for a few hours due to the pain; icing and elevating her leg, tramadol for intense pain/painful to the point of tears/pain that time was incredible; could feel the leg swell//could feel knee and calf swelling/swelling included full leg and ankle, swelling in the affected knee; icing for ankle swelled/swelling included full leg and ankle, intense pain/painful to the point of tears and stiffness in her knee/knee becoming stiff; not reported for could not sleep for more than 1 or 2 hours, discomfort in my knee much of the time, unable to climb the stairs/could not stand or walk or sit for any length time without pain.Outcome: unknown for all events seriousness criteria: disability for device malfunction and unable to climb the stairs/could not stand or walk or sit for any length time without pain a global pharmaceutical technical complaint was initiated with gptc number: 52340 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 26-feb-2018.The gptc number was added.Text amended accordingly.Additional information was received on 10-apr-2018 from patient.Verbatim of event use her husband's crutches to help her walk to use her husband's crutches to help her walk/walking with a limp/could not stand or walk or sit for any length time without pain.Verbatim of the event could feel the leg swell was updated to could feel the leg swell//could feel knee and calf swelling/swelling included full leg and ankle.Verbatim of event ankle swelled was updated to ankle swelled/swelling included full leg and ankle.Verbatim of event unable to climb the stairs was updated to unable to climb the stairs/could not stand or walk or sit for any length time without pain.Lubrication was added as indication of synvisc one.Event discomfort in my knee much of the time and could not sleep for more than 1 or 2 hours was added.Corrective treatment of the event intense pain/painful to the point of tears/pain that time was incredible was updated.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018:the follow up information dose not change the previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later had difficulty in walking for which patient used crutches.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: 7272476
• MDR Text Key: 100522944
• Report Number: 2246315-2018-00281
• 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: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 05/03/2018
• Patient Sequence Number: 1
• Treatment: SUBLIMAZE(PREV.)
• Patient Outcome(s): Disability
• Patient Age: 77 YR