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 Bone Fracture(s) (1870); Swelling (2091); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

(b)(4).This unsolicited case from united states was received on 08-dec-2017 from a nurse.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and on the same day could barely walk, could not bear weight and knee was swollen and after unknown latency had fracture in 5th metatarsal.Also device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, 1 df, once (batch/lot number: 7rsl021 and expiration date: not provided) for arthritis in knee.On the same day, patient's knee was swollen and she could barely walk.Patient also could not bear weight on the same day.Patient came back to the office on (b)(6) 2017.Her knee arthritis was stable at this point.The patient was complaining about another body part.On an unknown date, patient had a fracture in her 5th metatarsal.Corrective treatment: rest, ice and elevate and take anti-inflammatory medications for knee was swollen, could not bear weight and could barely walk; not reported for fracture in 5th metatarsal 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 for follow up dated 8-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and patient's knee was swollen, could barely walk and could not bear weight.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 is cross referred with the cases: (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from a nurse.This case concerns a 67 years old female patient who received treatment with synvisc one injection and after 1 day could barely walk, could not bear weight/unable to bear weight and knee was swollen/swollen knee; after 10 days had decreased stability and after unknown latency had fracture in 5th metatarsal and knee pain.Also device malfunction was identified for the reported lot number.Medical history included: anemia, diabetes, gout, kidney stones, heart disease, hypertension and hypercholesterolemia.Relevant concomitant medication included: clonidine, furosemide, glimepiride, sitagliptin phosphate (januvia), insulin glargine (lantus), potassium chloride, rosuvastatin, atorvatstatin, tamsulosin hydrochloride (tamsulosin), diclofenac sodium and telmisartan.Past drug and concurrent condition were not provided.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl019; expiration date: 01-may-2020) for osteoarthritis.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, 1 df, once (batch/lot number: 7rsl021 and expiration date: not provided) for osteoarthritis.On the same day, 1 day after receiving treatment with synvisc one, patient's knee was swollen and she could barely walk.Patient also could not bear weight on the same day.Patient came back to the office on (b)(6) 2017.Her knee arthritis was stable at this point.The patient was complaining about another body part.On (b)(6) 2017, 10 day after synvisc one injection, patient had decreased stability.On (b)(6) 2017, the patient recovered from could not bear weight/unable to bear weight, decreased stability and knee was swollen/swollen knee.On an unknown date, patient had a fracture in her 5th metatarsal.On an unknown date, after an unknown latency, patient had knee pain.Corrective treatment: rest, ice and elevate and take anti-inflammatory medications for knee was swollen/swollen knee, could not bear weight/unable to bear weight and could barely walk; not reported for other events outcome: unknown for knee pain; recovered/ resolved for could not bear weight/unable to bear weight, decreased stability, knee was swollen/swollen knee; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51055 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.Reporter causality: related for pain/swelling; not reported for rest of the events seriousness criteria: important medical event for device malfunction additional information was received on 17-jan-2018.Global ptc number was added.Follow up was received on 25-jan-2018.No new information was received.Additional information was received on 09-apr-2018 from nurse.Medical history and concomitant medication were added.Therapy regimen was added.Verbatim of event could not bear weight was updated to could not bear weight/unable to bear weight and verbatim of knee was swollen was updated to knee was swollen/swollen knee and their outcome was updated from not recovered to recovered.Additional events of knee pain and decreased stability were added along with details.Additional information was received on 09-apr-2018 from nurse.Medical history and concomitant medication were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 09-apr-2018: 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 is cross referred with the cases (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from a nurse.This case concerns a 67 years old female patient who received treatment with synvisc one injection and after 1 day could barely walk, could not bear weight/unable to bear weight and knee was swollen/swollen knee; after 10 days had decreased stability and after unknown latency had fracture in 5th metatarsal and knee pain.Also device malfunction was identified for the reported lot number.Medical history included: anemia, diabetes, gout, hypertension and hypercholesterolemia.Relevant concomitant medication included: clonidine, furosemide, glimepiride, sitagliptin phosphate (januvia), insulin glargine (lantus), potassium chloride, rosuvastatin and telmisartan.Past drug and concurrent condition were not provided.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection at a dose of 6 ml once (batch/ lot number: 7rsl019; expiration date: 01- may-2020) for osteoarthritis.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, 1 df, once (batch/lot number: 7rsl021 and expiration date: not provided) for osteoarthritis.On the same day, 1 day after receiving treatment with synvisc one, patient's knee was swollen and she could barely walk.Patient also could not bear weight on the same day.Patient came back to the office on (b)(6) 2017.Her knee arthritis was stable at this point.The patient was complaining about another body part.On (b)(6) 2017, 10 day after synvisc one injection, patient had decreased stability.On (b)(6) 2017, the patient recovered from could not bear weight/unable to bear weight, decreased stability and knee was swollen/swollen knee.On an unknown date, patient had a fracture in her 5th metatarsal.On an unknown date, after an unknown latency, patient had knee pain.Corrective treatment: rest, ice and elevate and take anti-inflammatory medications for knee was swollen/swollen knee, could not bear weight/unable to bear weight and could barely walk; not reported for other events outcome: unknown for knee pain; recovered/ resolved for could not bear weight/unable to bear weight, decreased stability, knee was swollen/swollen knee; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51055 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.Reporter causality: related for pain/swelling; not reported for rest of the events seriousness criteria: important medical event for device malfunction additional information was received on 17-jan-2018.Global ptc number was added.Follow up was received on 25-jan-2018.No new information was received.Additional information was received on 09-apr-2018 from nurse.Medical history and concomitant medication were added.Therapy regimen was added.Verbatim of event could not bear weight was updated to could not bear weight/unable to bear weight and verbatim of knee was swollen was updated to knee was swollen/swollen knee and their outcome was updated from not recovered to recovered.Additional events of knee pain and decreased stability were added along with details.Pharmacovigilance comment: sanofi company comment for follow up dated 09-apr-2018: 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: 7178252
• MDR Text Key: 97862041
• Report Number: 2246315-2018-00085
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• 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: 04/09/2018
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN(CON.); CLONIDINE(CON.); CLONIDINE(CON.); DICLOFENAC SODIUM(CON.); FUROSEMIDE(CON.); FUROSEMIDE(CON.); GLIMEPIRIDE(CON.); GLIMEPIRIDE(CON.); JANUVIA(CON.); JANUVIA(CON.); LANTUS(CON.); LANTUS(CON.); POTASSIUM CHLORIDE(CON.); POTASSIUM CHLORIDE(CON.); ROSUVASTATIN(CON.); ROSUVASTATIN(CON.); TAMSULOSIN(CON.); TELMISARTAN(CON.); TELMISARTAN(CON.)
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 115