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 Diarrhea (1811); Fungus (1872); Nausea (1970); Pain (1994); Rash (2033); Swelling (2091); Vomiting (2144); Weight Changes (2607)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from patient.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after few days when walking her knees hurts on the outside of the legs, her skin is getting fatter, she broke in a rash under breast, on each side of her waist and on the butt/rash is a fungus/rash, waist is still sore, knee hurting on top of the knees/both knees are bothering her/when walking her knees hurts on the outside of the legs/pain in her knees/pain was between 6 or 7/pain worsen after injection and swelling in her knees/knees are twice the size, after 13 days had nausea, vomiting, diarrhea.Also device malfunction was identified for the reported lot number.Medical history included high blood pressure, diabetes mellitus type ii (dmii), and osteoarthritis of both knees.Patient did not receive any other injection prior to treatment with synvisc or other hyaluronan products.Patient did not have any prosthetic device e.G.Prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator.Patient did not had allergy history: avian proteins, feathers, or egg products.Patient did not receive any concomitant medications.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 48 mg, once (batch/lot number: 7rsl021 and expiration date: not provided) in both knees for osteoarthritis both knees.Patient did not engage in activities such as jogging or tennis soon after the injection.It was reported that before the injection her pain was between 4 to 5.On an unknown date in (b)(6) 2017, few days after the injection, patient's knee was hurting on top of the knees, her skin was getting fatter, both knees were bothering her.While walking, patient's knees hurts on the outside of the legs.Patient's knees were twice the size they were before the injections and the pain was between 6 or 7 on pain scale.On an unknown date in (b)(6) 2017, few days after the injection, patient broke in a rash under breast, on each side of her waist and on the butt.As of (b)(6) 2017, patient still had the rash in those areas.The physician told her that the rash was a fungus.Patient was prescribed a fungal cream and fungal pills to take.The nurses in the home would wash off the rash areas with foam disinfectant then applied the fungal cream.Patient took the fungal pills for 5 days but it did not work she still had the rash.On (b)(6) 2017, at 2:00 am, 13 days after the injection, patient started experiencing nausea, vomiting and diarrhea which lasted for four days.On (b)(6) 2017, nausea, vomiting and diarrhea had resolved.Patient had recovered but her waist was still sore from the nausea, vomiting, and diarrhea.At this time, patient was still recovering from the knees and the rashes.Patient was able to bear weight before and after the injection with her walker and was still walking with her walker.No further information provided.Corrective treatment: fungal cream, fungal pills for she broke in a rash under breast, on each side of her waist and on the butt/rash is a fungus/rash, not reported for other events.Outcome: recovering for knee hurting on top of the knees/both knees are bothering her/when walking her knees hurts on the outside of the legs/pain in her knees/pain was between 6 or 7/pain worsen after injection, swelling in her knees/knees are twice the size, when walking her knees hurts on the outside of the legs, she broke in a rash under breast, on each side of her waist and on the butt/rash is a fungus/rash and recovered for nausea, vomiting and diarrhea and unknown for other 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment for dated 28-dec-2017: this case concerns a patient who suffered from leg pain, skin disorder, fungal rash, nausea, vomiting, diarrhea, pain, bilateral knee pain, and swelling of knees after receiving synvisc one injection from the recalled lot.Temporal relationship can be established only for the event of leg pain, bilateral knee pain and swelling of knees with the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company, therefore, the pharmacological plausibility for the event of leg pain, bilateral knee pain and swelling of knees to the product cannot be excluded.

Event Description

This unsolicited case from united states was received on 21-dec-2017 from patient.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after few days when walking her knees hurts on the outside of the legs/hurt on the out side of leg half way down to the angle hurts, her skin is getting fatter, she broke in a rash under breast, on each side of her waist and on the butt/rash is a fungus/rash, waist is still sore, after 13 days had nausea, vomiting, diarrhea, when walking her knees hurts on the outside of the legs/hurt on the out side of leg half way down to the angle hurts, swollen leg, swelling in her knees/knees are twice the size/swollen above the knee and below the knee, stomach was swollen, lost 8 pounds, was sick.Also device malfunction was identified for the reported lot number.Medical history included high blood pressure, cholesterol abnormal, anxiety, diabetes mellitus type ii (dmii), and osteoarthritis of both knees.Patient did not receive any other injection prior to treatment with synvisc or other hyaluronan products.Patient did not have any prosthetic device e.G.Prosthetic hip/ knee, prosthetic valve, pacemaker and or defibrillator.Patient did not had allergy history: avian proteins, feathers, or egg products.Patient did not receive any concomitant medications.Concomitant medications included: simvastatin, meloxicam, lisinopril, metformin hydrochloride (metformin), sertraline hydrochloride on (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 48 mg, once (batch/lot number: 7rsl021 and expiration date: not provided) in both knees for osteoarthritis both knees.Patient did not engage in activities such as jogging or tennis soon after the injection.It was reported that before the injection her pain was between 4 to 5.On an unknown date in (b)(6) 2017, few days after the injection, patient's knee was hurting on top of the knees, her skin was getting fatter, both knees were bothering her.While walking, patient's knees hurts on the outside of the legs.Patient's knees were twice the size they were before the injections and the pain was between 6 or 7 on pain scale (onset: (b)(6) 2017; latency: 13 days).On an unknown date in (b)(6) 2017, few days after the injection, patient broke in a rash under breast, on each side of her waist and on the butt.As of (b)(6) 2017, patient still had the rash in those areas.The physician told her that the rash was a fungus.Patient was prescribed a fungal cream and fungal pills to take.The nurses in the home would wash off the rash areas with foam disinfectant then applied the fungal cream.Patient took the fungal pills for 5 days but it did not work she still had the rash.On (b)(6) 2017, at 2:00 am, 13 days after the injection, patient started experiencing nausea, stomach was swollen, lost 8 pounds, was sick vomiting, swollen leg and diarrhea which lasted for four days.On (b)(6) 2017, nausea, vomiting and diarrhea had resolved.Patient had recovered but her waist was still sore from the nausea, vomiting, and diarrhea.At this time, patient was still recovering from the knees and the rashes.Patient was able to bear weight before and after the injection with her walker and was still walking with her walker.No further information provided.Corrective treatment: fungal cream, fungal pills for she broke in a rash under breast, on each side of her waist and on the butt/rash is a fungus/rash, not reported for other events outcome: recovering for knee hurting on top of the knees/both knees are bothering her/when walking her knees hurts on the outside of the legs/pain in her knees/pain was between 6 or 7/pain worsen after injection, swelling in her knees/knees are twice the size, when walking her knees hurts on the outside of the legs, she broke in a rash under breast, on each side of her waist and on the butt/rash is a fungus/rash and recovered for nausea, vomiting and diarrhea and unknown for other 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction additional information was received on 17-jan-2018 from the patient.Events of lost 8 pounds, sick, stomach was swollen, swollen leg were added.Concomitant medications were added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for dated 28-dec-2017: this case concerns a patient who suffered from leg pain, skin disorder, fungal rash, nausea, vomiting, diarrhea, pain, bilateral knee pain, and swelling of knees after receiving synvisc one injection from the recalled lot.Temporal relationship can be established for the events of leg pain, swollen leg, bilateral knee pain, nausea, vomiting, diarrhea,swollen abdomen, weight loss,sickness and swelling of knees with the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company, therefore, the pharmacological plausibility for these events 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: 7178890
• MDR Text Key: 97976017
• Report Number: 2246315-2017-00600
• 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: 12/21/2017

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: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 02/05/2018
• Patient Sequence Number: 1
• Treatment: LISINOPRIL(CON.); MELOXICAM(CON.); METFORMIN(CON.); SERTRALINE HYDROCHLORIDE(CON.); SIMVASTATIN(CON.)
• Patient Outcome(s): Other
• Patient Age: 85 YR