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); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Date 11/07/2017

Event Type  malfunction  

Event Description

Based on additional information received on 06-feb- 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 14-dec-2017 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and the same day patient could not walk, could not put pressure on the leg/could not put pressure on knee, swelling/swollen knee and just sore/ hurts every now and then and when she gets off work and lays down it starts throbbing/ pain immediately, fever, weak and could not go to work/ unable to function; after unknown latency patient had stiffness; also, device malfunction was identified for the reported lot number.Patient had past treatment with synvisc one (for the last couple of years or maybe three years and that she gets it every 6 months).The patient was not allergic to avian proteins, feathers, or egg products.Concomitant medications included metformin and pioglitazone for diabetes, losartan for high blood pressure.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, once (dose and indication: unknown; lot number: 7rsl021 expiration date: may-2020) into the right knee.The same day, the knee got swollen and had pain immediately after the injection (less than 24 hours).Patient could not put the pressure in knee, could not walk and patient could not put any pressure on her leg (latency: 0 day).Patient could not walk due to which she missed treatment with synvisc one.On an unknown date, first night she had a lot of swelling and stiffness which was really unusual and just sore the first night but not enough to put ice on it.Patient stated that when she got up the next day she could not work because it was throbbing and stiff and she start crying.It was reported that when the patient called the doctor and they said it was "kind of normal" but she said it was not normal for her.The patient was told to elevate it and put ice on it and the next day it was the same way.She states that the only thing her doctor has told her is to just put ice on it and keep it elevated and stay off of it as much as she can.It was reported that this was no problem because she could not stand on it.Patient had fever, weak and was unable to function.Reportedly, it still hurts every now and then and when she gets off work and lays down it starts throbbing.She states that usually when she lies down it doesn't throbs but now it was throbbing when she is on it and laying down.She denied any prosthetic devices.Patient was advised to continue to stay off the leg for 2-3 days, put ice and elevate.The side effects lasted for 4-5 days and patient could not go to work.Corrective treatment: ice and elevate for could not walk, could not put pressure on the leg/could not put pressure on knee, swelling/swollen knee, stiffness; ice, elevate, celecoxib for just sore/ hurts every now and then and when she gets off work and lays down it starts throbbing/pain immediately; not reported for rest outcome: not recovered for all the events.A global pharmaceutical technical complaint was initiated and ptc results were pending for the same.Seriousness criterion: important medical event of device malfunction.Additional information was received on 06-feb-2018.Medical history and concomitant medications were added.Product lot number and expiration date was added.Additional events of fever, weak, device malfunction and could not go to work/ unable to function were added with details.Event verbatim of swelling/swollen knee and just sore/ hurts every now and then and when she gets off work and lays down it starts throbbing/pain immediately and could not put pressure on the leg/could not put pressure on knee was updated along with its outcome.Event onset date of could not put pressure on the leg/could not put pressure on knee, swelling/swollen knee and just sore/ hurts every now and then and when she gets off work and lays down it starts throbbing/pain immediately was updated.Seriousness criterion was added.Action taken was updated.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 06-feb-2018: this case concerns a patient who suffered from being unable to walk, weak, fever, weight bearing difficulty, impaired work ability, swelling of right knee, right knee stiffness and right knee pain after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility 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: 7279698
• MDR Text Key: 100655735
• Report Number: 2246315-2018-00314
• 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: 12/14/2017

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: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/19/2018
• 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: 58 YR