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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Arthralgia (2355); No Code Available (3191)

Event Date 12/18/2018

Event Type  malfunction  

Event Description

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 injection and on the same day, patient could not walk, could not bear weight, knee hot and after unknown latency patient had pain and knee was worse after receiving the injection no concomitant medication was provided.The patient had not had previous synvisc one injections; she has had previous cortisone injections.The patient stated that she had an injury at work, (b)(6) 2017 and had the synvisc one injection sometime after that, before coming back to work in (b)(6) 2017.Before the injection, patient pain level was about 8 out of 10, she had trouble bearing weight on the knee, but she did not have to use a cane or crutches.Patient did not have any prostheses and has no avian or egg allergy.Patient did not have diabetes and was not being treated for any chronic disease.On an unknown date in 2017, patient initiated treatment with intra- articular synvisc one injection (dose, frequency, batch/lot number and expiration date: not provided) for arthritis in left knee.On the same day patient stated that she had the injection in the morning and by that evening, she could not do anything.Patient could not walk or bear weight and the knee was hot.Patient did not have a fever.The patient used crutches for two weeks, then used a cane for a time.Patient was able to stop using the cane, but then had to use it again every few days for a while.After the injection, her pain level was past 10 out of 10 (onset date: 2017; latency unknown).Patient stated that her knee was worse after receiving the injection than before.Patient called the doctor, who prescribed tramadol for the pain, but no fluid was drawn from the knee.The patient stated that she was fine now.Corrective treatment: crutches, cane for could not walk, could not bear weight, pain; tramadol hydrochloride (tramadol) for pain; not reported for knee hot and knee was worse after receiving the injection outcome: recovering for all events a pharmaceutical technical complaint was initiated with results pending for the same.Seriousness criterion: disability for could not walk, could not bear weight, pain pharmacovigilance comment: sanofi company comment dated 03-feb-2018: this case concerns a female patient who received synvisc one injection for arthritis and later reported worsening of his condition with knee pain and that she could not walk and bear weight and had to use crutches and cane.Based upon the temporal relationship, the causal role of the product cannot be denied with the occurrence of events.However, further information regarding patient's current clinical presentation, technique of injection, any other concomitant medications and other risk factors would help in the complete medical assessment of the case.

Event Description

This unsolicited case from united states was received on 29-jan-2018 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and on the same day, patient could not walk, could not bear weight, knee hot and after unknown latency patient had pain and knee was worse after receiving the injection no concomitant medication was provided.The patient had not had previous synvisc one injections; she has had previous cortisone injections.The patient stated that she had an injury at work, late (b)(6) or early (b)(6) 2017 and had the synvisc one injection sometime after that, before coming back to work in (b)(6) 2017.Before the injection, patient pain level was about 8 out of 10, she had trouble bearing weight on the knee, but she did not have to use a cane or crutches.Patient did not have any prostheses and has no avian or egg allergy.Patient did not have diabetes and was not being treated for any chronic disease.On an unknown date in 2017, patient initiated treatment with intra- articular synvisc one injection (dose, frequency, batch/lot number and expiration date: not provided) for arthritis in left knee.On the same day patient stated that she had the injection in the morning and by that evening, she could not do anything.Patient could not walk or bear weight and the knee was hot.Patient did not have a fever.The patient used crutches for two weeks, then used a cane for a time.Patient was able to stop using the cane, but then had to use it again every few days for a while.After the injection, her pain level was past 10 out of 10 (onset date: 2017; latency unknown).Patient stated that her knee was worse after receiving the injection than before.Patient called the doctor, who prescribed tramadol for the pain, but no fluid was drawn from the knee.The patient stated that she was fine now.Corrective treatment: crutches, cane for could not walk, could not bear weight, pain; tramadol hydrochloride (tramadol) for pain; not reported for knee hot and knee was worse after receiving the injection outcome: recovering for all events a pharmaceutical technical complaint (ptc) was initiated with (b)(4) the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for could not walk, could not bear weight, pain additional information was received on 05-feb-2018.Global ptc number and ptc results added.Text was amended accordingly pharmacovigilance comment: sanofi company comment for follow up dated 05-feb-2018: follow up received does not change previous case assessment.This case concerns a female patient who received synvisc one injection for arthritis and later reported worsening of his condition with knee pain and that she could not walk and bear weight and had to use crutches and cane.Based upon the temporal relationship, the causal role of the product cannot be denied with the occurrence of events.However, further information regarding patient's current clinical presentation, technique of injection, any other concomitant medications and other risk factors would help in the complete medical assessment of the case.

Event Description

This unsolicited case from united states was received on 29-jan-2018 from a patient.This case concerns a 65 year old female patient who received treatment with synvisc one injection and on the same day, patient could not walk, could not bear weight, knee hot and after unknown latency patient had pain and knee was worse after receiving the injection.Also device malfunction was identified for the reported lot number.No concomitant medication was provided.The patient had not had previous synvisc one injections; she has had previous cortisone injections.The patient stated that she had an injury at work, late september or early october 2017 and had the synvisc one injection sometime after that, before coming back to work in dec-2017.Before the injection, patient pain level was about 8 out of 10, she had trouble bearing weight on the knee, but she did not have to use a cane or crutches.Patient did not have any prostheses and has no avian or egg allergy.Patient did not have diabetes and was not being treated for any chronic disease.On 18-dec-2017, patient initiated treatment with intra- articular synvisc one injection (dose, frequency, batch/lot number: 7rsl021 and expiration date: not provided) for arthritis in left knee.On the same day patient stated that she had the injection in the morning and by that evening, she could not do anything.Patient could not walk or bear weight and the knee was hot.Patient did not have a fever.The patient used crutches for two weeks, then used a cane for a time.Patient was able to stop using the cane, but then had to use it again every few days for a while.After the injection, her pain level was past 10 out of 10 (onset date: 2017; latency unknown).Patient stated that her knee was worse after receiving the injection than before.Patient called the doctor, who prescribed tramadol for the pain, but no fluid was drawn from the knee.The patient stated that she was fine now.Corrective treatment: crutches, cane for could not walk, could not bear weight, pain; tramadol hydrochloride (tramadol) for pain; not reported for knee hot and knee was worse after receiving the injection outcome: recovering for all events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52306 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 would be completed, corrective and preventive actions would be implemented.Seriousness criterion: disability for could not walk, could not bear weight, pain, device malfunction additional information was received on 05-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Follow-up information was received on information was received on 05-feb-2018.No new information was received.Additional information was received on 22-feb-2018 from patient.Suspect start date and lot number was added.Event start dates of patient could not walk, could not bear weight, knee hot were added.Additional event of device malfunction was added.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-feb-2018: this case concerns a female patient who received synvisc one injection from the recalled lot for arthritis and later reported worsening of his condition with knee pain and that she could not walk and bear weight and had to use crutches and cane.Based upon the temporal relationship, the causal role of the product cannot be denied with the occurrence of events.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
• MDR Report Key: 7275960
• MDR Text Key: 100239995
• Report Number: 2246315-2018-00278
• 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,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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: 02/22/2018
• Patient Sequence Number: 1
• Treatment: CORTISONE(PREV.); CORTISONE(PREV.); CORTISONE(PREV.); CORTISONE(PREV.)
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Weight: 93