MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(4) 2017 from patient's husband.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after unknown latency knee locked up, couldn't walk, couldn't move the knee, infection, lot of pain and knee was swollen.Also device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.Patient did not had any prosthetic devices and denied any treatment with immunosuppressants.Patient had no allergies to avian proteins, feathers, or egg products.Patient had received flu shot earlier this year.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number: 7rsl021 and expiration date, dose, indication: not provided) in right knee.Patient had a very bad reaction.It was reported that the reaction happened very fast and patient was told not to exert for three days.Patient did not engage in activities such as jogging or tennis after receiving the injection.On an unknown date in (b)(6) 2017, patient's knee locked up and she could not move it, was in a lot of pain and could not get out of bed.The physician told her to take three 200 mg of ibuprofen (advil or motrin) along with benadryl and to also take two 25 mg tablets.Also reported that the provider admitted on (b)(6) 2017 that he might had given her the wrong medication by mistake.Patient was also given ciprofloxacin (cipro) to take twice a day to ward off the infection.Physician told the patient that it may or may not spread and that they should watch it for a week.It was reported that the patient's knee was swollen and she couldn't walk but now she felt a little better and that it might be due to the anti-inflammatory.Patient's overall health was good and she had no problems as she had received a flu shot earlier this year.Corrective treatment: ciprofloxacin for infection, ibuprofen for lot of pain and not reported for other events except device malfunction outcome: not recovered 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 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 dated (b)(4) 2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced joint lock, walking difficulty, joint range of motion decreased, infection and right knee pain and swelling.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 case was cross referred with case: (b)(4) (duplicate).This unsolicited case from united states was received on 27-dec-2017 from patient's husband.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and on the same day couldn't walk/ could not walk; after unknown latency knee locked up, couldn't move the knee, infection, could not move right leg as she was dragging it and inflammation.Also device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.Patient did not had any prosthetic devices and denied any treatment with immunosuppressants.Patient had no allergies to avian proteins, feathers, or egg products.Patient had received flu shot earlier this year.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number: 7rsl021 and expiration date, dose, indication: not provided) in right knee.Patient had a very bad reaction.It was reported that the reaction happened very fast and patient was told not to exert for three days.Patient did not engage in activities such as jogging or tennis after receiving the injection.By the afternoon, patient could not walk (latency: 0 day).In fact, while at home, patient accidentally "peed in the clothes" because patient could not get to the bathroom in time.On (b)(6) 2017, patient saw the attending orthopedist again who had informed that patient had received the wrong batch of the affected recall lot number due to some "mix up" at the office by a medical assistant.As a result, the orthopedist aspirated the intraarticular fluid "containing the injected synvisc one product".Since the injection offered no benefit, patient needed another injection of synvisc one which is why patient was requesting replacement because medicare would not cover another injection.The related inflammation and pain (scale of 9 or 10 out of 10) might be so bad that patient could not move her right leg and was dragging it (latency: unknown).As treatment, patient took ibuprofen and the swelling had gone down with the pain now being a 6 out of 10 with lying down.On an unknown date in (b)(6) 2017, patient's knee locked up and she could not move it, was in a lot of pain and could not get out of bed.The physician told her to take three 200 mg of ibuprofen (advil or motrin) along with benadryl and to also take two 25 mg tablets.Also reported that the provider admitted on (b)(6) 2017 that he might had given her the wrong medication by mistake.Patient was also given ciprofloxacin (cipro) to take twice a day to ward off the infection.Physician told the patient that it may or may not spread and that they should watch it for a week.It was reported that the patient's knee was swollen and she couldn't walk but now she felt a little better and that it might be due to the anti-inflammatory.Patient's overall health was good and she had no problems as she had received a flu shot earlier this year.Corrective treatment: ciprofloxacin for infection, ibuprofen for inflammation and not reported for other events except device malfunction outcome: recovering for couldn't walk/ could not walk; unknown for could not move right leg as she was dragging it and inflammation; not recovered for other 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction follow up information was received on 15-jan-2018.Global ptc number was added.Text was amended accordingly.Additional information was received on 29-jan-2018 from the patient.Events of inflammation and couldn't move the knee were added.Events of lot of pain and knee was swollen were made symptoms of inflammation.All the information of case (b)(4) was merged into case (b)(4).Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 29-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced joint lock, walking difficulty, joint range of motion decreased, infection and right knee pain and swelling.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: 7208778
• MDR Text Key: 98295947
• Report Number: 2246315-2018-00049
• 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: 12/27/2017
• 2 Devices were Involved in the Event: 1 2

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: 01/29/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 73