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 Muscular Rigidity (1968); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

Based on additional information received on (b)(6) 2018, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction).This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and later after 1 day couldn't hardly walk/ couldn't walk on my leg/ wasn't walking right, leg swelled up real bad/it was so swollen, stiff/ it was so stiff and after 2 days could n't bend my knee, knee was extremely swollen and knee was extremely painful.Also, device malfunction was identified for the reported lot number.No concurrent condition was provided.Relevant concomitant medications included ibuprofen, paracetamol (tylenol).On (b)(6) 2017, the patient had x-ray which showed bone on bone both knees.Relevant medical history included little bit of high blood pressure, previous back surgery, 2 c-sections, tubal ligation and gall bladder removed, the patient was allergic to levofloxacin (levaquin), sulfur-rashed make her sick.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (batch/lot number: 7rsl021; dose, frequency: unknown) into the right knee.The synvisc-one shot didn't hurt.It was reported that they used an ultrasound to give it and compared to getting steroid shot, the pain of the synvisc-one shot was nothing.No numbing agent was used.They prepared the synvisc-one in front of patient.On the same day, knee was fine.The patient was walking around a lot.The patient did a lot of walking but they didn't tell her not to stay off of it.It was reported patient walked around doing normal activities.The patient was a pretty active person when not in pain.It was reported that the patient receive only one dose of synvisc one injection.On (b)(6) 2017, 1 day after receiving synvisc one injection, it was ok until that evening.Then on the same day, the patient couldn't hardly walk and was stiff and leg swelled up real bad.It was reported that on the evening of (b)(6) 2017 the patient experienced stiffness and then extreme swelling so much so that the patient was unable to walk the next day and had to use crutches to get around.On (b)(6) 2017, the patient couldn't walk on leg and it was so swollen/stiff and couldn't bend knee.In order to get around patient used crutches.Pain from swelling and this lasted for at least 2 weeks.The patient called the doctor and didn't get a call back for over two weeks.It was reported that the patient used ice, stayed off feet and knee stayed that way for 2 weeks.The patient's knee was extremely swollen and painful.Patient was on crutches for a day or two.It was reported that patient wasn't walking right.The patient called the doctor several times and they never called back.The patient thought that she was going to lose leg.It was reported that the doctor told her to keep doing what she was doing.The patient was told to sleep with leg up in the air for 2 weeks which she did.The patient did not sleep like this well.It was reported that patient had it iced the whole time.The swelling went away after about two weeks or so.The doctor did not aspirate the knee.The injection didn't do anything for pain.The patient's pain was high right now and it was exhausting living like this.I was an emotional mess and crying.It was reported that nothing was going to solve the pain that patient was in until the complete knee surgery.It was reported that patient was scheduled for surgery next week for a total knee replacement.Patient was looking for something to help get through to the new year for surgery.The patient was looking for relief but didn't get it from the synvisc-one.Something else patient was upset about is that the synvisc-one was offered as an option but it really wasn't one.The doctor didn't say that if patient don't have cartilage don't use it and that this is not a good option.Action taken: unknown corrective treatment: crutches for could n't bend my knee, couldn't hardly walk/ couldn't walk on my leg/wasn't walking right, used ice, stayed off my feet, leg up in the air for leg swelled up real bad/it was so swollen, used ice, stayed off my feet for stiff/ it was so stiff, used ice, leg up in the air for knee was extremely swollen, iced for knee was extremely painful; not reported for device malfunction outcome: recovered/resolved for knee was extremely painful; unknown for device malfunction; not recovered for rest of the events seriousness criteria: important medical event for device malfunction a global pharmaceutical technical complaint was initiated with global ptc number 52036.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.Additional information was received on (b)(6) 2018 from the patient.This case initially considered as nonserious was upgraded to serious (important medical event of device malfunction).Lot number of suspect product was added.Outcome of knee was extremely painful was updated to recovered.Medical history and concomitant medications were added.Stop date of synvisc one was added.Clinical course was updated.Text was amended accordingly pharmacovigilance comment: sanofi company comment for follow up dated 27-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later could not bend knee, could hardly walk, leg swelling, stiff feet, knee swelling and pain.A temporal relationship can be established with the product administration.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship 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: 7333456
• MDR Text Key: 102465608
• Report Number: 2246315-2018-00380
• 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
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• 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: 46 YR