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 Nausea (1970); Chills (2191); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544)

Event Date 12/04/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 26-dec-2017 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and after few hours had excruciating pain on both knees/sharp pain around the knees; after unknown latency couldn't stand up/ couldn't stand, couldn't walk/trouble walking, knee locking, nausea, chills and both knees were very swollen/swelling around the knee cap.Also device malfunction was identified for the reported lot number.No concomitant medication, medical history or concurrent condition was provided.Patient has taken synvisc-one in the past she has never experienced this before.Patient also stated that she has had products like synvisc one in the past before.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021 and expiry date: unknown) in both knees for knee osteoarthritis.On the same day, by 4:30 pm that day patient experience excruciating pain on both knees.On an unknown date in (b)(6) 2017, after unknown latency, patient stated that she was sitting for about 45 minutes and she almost could not stand up and both knees were very swollen, and she had to hold on to furniture to walk.Patient was in so much pain that she was thinking about going to the er (emergency room), but did not.Patient has also experience chills, nausea, she could not stand or walk until the evening of the (b)(6) 2017.Saturday the (b)(6), patient was a little bit better but still had swelling.Patient started to feel improved on (b)(6) 2017.The office staff told patient to take ibuprofen and apply heat.They said that they informed patient that this sometimes happens with the shots.Patient stated that she experienced swelling and sharp pain around the knee cap and that it also extended down towards her shin towards her feed.Patient stated that she has also had knee locking and trouble walking.Patient did not engage in any activity after the injection.Patient confirmed that she was considering going to the er (emergency room) but she did not go.Patient also stated that she had stopped using knee injections in the past because she had not needed them but recently in the past year she has needed to take them.Patient also does not know of any other medication injected into the knee at the time of the procedure.Patient was also concerned if this would lead to future problems corrective treatment: ibuprofen and apply heat for both knees were very swollen/swelling around the knee cap and excruciating pain on both knees/sharp pain around the knees; not reported for rest events outcome: recovering for all 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 was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 3-jan-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced difficulty in standing and walking.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 unsolicited case from united states was received on 26-dec-2017 from the patient.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and after few hours had excruciating pain on both knees/sharp pain around the knees/ terrible pain/ very bad pain/ aches; after unknown latency couldn't stand up/couldn't stand/ managed to stand up with great difficulty/ problem standing up from sitting position, couldn't walk/ trouble walking/ walked with great difficulty/ occasional problem walking, knee locking, nausea, chills and both knees were very swollen/swelling around the knee cap/ joint swelling, on the same day felt as if going into shock, cramps, stiffness, joint discomfort.Also device malfunction was identified for the reported lot number.Patient has taken synvisc-one in the past she has never experienced this before.Patient also stated that she has had products like synvisc one in the past before.Relevant concurrent conditions included some osteoarthritis, blood pressure.Relevant concomitant medications included atenolol for blood pressure.On (b)(6) 2017, around 10:30 am, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021 and expiry date: unknown) in both knees for knee osteoarthritis.On the same day, by 4:30 pm that day patient experience excruciating pain on both knees.It was reported that terrible pain started at around 04:30 pm, the patient tried to stand up from stair.Very bad pain started but the patient managed to stand up and walked with great difficulty.For two plus half days (3 days), the patient could not stand up nor walk at all.The patient had terrible pain, nausea, chill and felt as if going to go into shock.The patient experiencing aches, pain, some chill, joint swelling continued.The patient did not visit the emergency room for the problem but felt like she should have because of terrible pain and not able to stand nor walk.On (b)(6) 2017, the patient called on clinic.On an unknown date in (b)(6) 2017, after unknown latency, patient stated that she was sitting for about 45 minutes and she almost could not stand up and both knees were very swollen, and she had to hold on to furniture to walk.Patient was in so much pain that she was thinking about going to the er (emergency room), but did not.Patient has also experience chills, nausea, she could not stand or walk until the evening of the (b)(6) 2017.Saturday the 9th, patient was a little bit better but still had swelling.The patient was not able to stand nor walk, almost normal until (b)(6) 2017.Patient started to feel improved on (b)(6) 2017.The office staff told patient to take ibuprofen and apply heat.They said that they informed patient that this sometimes happens with the shots.Patient stated that she experienced swelling and sharp pain around the knee cap and that it also extended down towards her shin towards her feed.Patient stated that she has also had knee locking and trouble walking.Patient did not engage in any activity after the injection.Patient confirmed that she was considering going to the er (emergency room) but she did not go.Patient also stated that she had stopped using knee injections in the past because she had not needed them but recently in the past year she has needed to take them.Patient also does not know of any other medication injected into the knee at the time of the procedure.Patient was also concerned if this would lead to future problems.On (b)(6) 2018, the patient had an appointment with doctor and on the same day blood samples were drawn for blood culture.On an unknown date, fluid from both knees were taken.At the time of report on (b)(6) 2018, some pain, swelling, cramps, stiffness, joint discomfort, occasional problem walking, problem standing up from sitting position was ongoing.Corrective treatment: ibuprofen and apply heat for both knees were very swollen/swelling around the knee cap/ joint swelling and excruciating pain on both knees/sharp pain around the knees/ terrible pain/ very bad pain/ aches; none for couldn't stand up/couldn't stand/ managed to stand up with great difficulty/ problem standing up from sitting position, couldn't walk/trouble walking/ walked with great difficulty/ occassional problem walking, nausea, chills, felt as if going into shock, cramps, stiffness, joint discomfort; not reported for knee locking, device malfunction outcome: recovering for all events a pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).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 was completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction follow up was received on 09-feb-2018 and global ptc number was added.Additional information was received on 20-feb-2018 from the patient.Event term of excruciating pain on both knees/sharp pain around the knees was updated to excruciating pain on both knees/sharp pain around the knees/ terrible pain/ very bad pain/ aches; couldn't stand up/couldn't stand was updated to couldn't stand up/couldn't stand/ managed to stand up with great difficulty/ problem standing up from sitting position, couldn't walk/trouble walking was updated to couldn't walk/trouble walking/ walked with great difficulty/ occasional problem walking and both knees were very swollen/swelling around the knee cap was updated to both knees were very swollen/swelling around the knee cap/ joint swelling.Additional events of felt as if going into shock, cramps, stiffness, joint discomfort were added with details.Concurrent conditions were added.Concomitant medications were added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 20-feb2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced difficulty in standing and walking,felt as if going into shock, cramps, stifness and joint discomfort.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: 7208768
• MDR Text Key: 97944456
• Report Number: 2246315-2018-00036
• 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: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Patient Sequence Number: 1
• Treatment: ATENOLOL(CON.); SYNVISC ONE(PREV.); SYNVISC ONE(PREV.)
• Patient Outcome(s): Other
• Patient Age: 69 YR