MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL019

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Erythema (1840); Pain (1994); Arthralgia (2355); No Code Available (3191)

Event Date 11/17/2017

Event Type  Injury  

Event Description

(b)(4).This unsolicited case from united states was received on 08-dec-2017 from a nurse.This case concerns (b)(6) female patient who received treatment with synvisc one and later after 3 days had increased pain and after unknown latency knee was warm to touch.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once at a dose of 1 df into the left knee for left knee arthritis (batch/ lot number: 7rsl021; expiry date: unknown).On (b)(6) 2017, (latency 3 days), the patient complained of increased pain.The patient was told to rest, ice and elevate and take anti-inflammatory drugs.On (b)(6) 2017, the patient called and said that she was using crutches.It was reported that the patient had had iced.On an unknown date in 2017, after unknown latency, the patient's knee was warm to touch.The patient was been taking paracetamol (tylenol) only.She switched to taking naproxen sodium (aleve).Corrective treatment: rest, ice and elevate and take anti-inflammatory drugs, paracetamol (tylenol naproxen sodium (aleve) for increased pain; ice for knee warm to touch.Outcome: not recovered for all the 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 would be completed, corrective and preventive actions would be implemented pharmacovigilance comment: sanofi company comment dated 08-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot for left knee arthritis and later had increased pain and her knee was warm to touch.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 referenced with case: (b)(4).This unsolicited case from united states was received on 08-dec-2017 from a nurse.This case concerns 71 years old female patient who received treatment with synvisc one and later after 3 days had increased pain, knee swollen, knee redness and after unknown latency knee was warm to touch.Also device malfunction was identified for the reported lot number.Medical history included hypercholesterolemia, insomnia, asthma and anemia.Concomitant medications included armodafinil, atorvastatin, escitalopram oxalate (escitalopram), estradiol (estrace), nabumetone, salbutamol sulfate (proair) and ibandronate sodium (boniva).No past drug and concurrent condition were provided.On (b)(6) 2017 , the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl019; expiry date: 01-may-2020).On (b)(6) 2017 , the patient initiated treatment with intra-articular synvisc one injection once at a dose of 1 df into the left knee for left knee arthritis (batch/lot number: 7rsl021; expiry date: unknown).On the same day, the patient complained of increased pain.The patient was told to rest, ice and elevate and take anti-inflammatory drugs.On (b)(6) 2017, the patient called and said that she was using crutches.It was reported that the patient had had iced.Also, the patient's knee was swollen and red.On an unknown date in 2017, after unknown latency, the patient's knee was warm to touch.The patient was been taking paracetamol (tylenol) only.She switched to taking naproxen sodium (aleve).Later, on an unknown date in 2017, patient recovered from all events.Corrective treatment: rest, ice and elevate and take anti-inflammatory drugs, paracetamol (tylenol naproxen sodium (aleve), crutches for increased pain; ice for knee warm to touch, unknown for knee swollen and knee redness.Outcome: recovered for all the events seriousness crietria: disability for increased pain and device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number 51054.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.Follow up was received on 17-jan-2018.Global ptc number was added.Additional information was received on 09-apr-2018 from nurse.Medical history and comcomitant mediccations added.Patient's demographics (height and weight) added.Additional events of knee swollen and knee redness added with details.Additional dosing regimen with details added.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 09-apr-2018: follow up information received doesnot change previous case assessment.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.

Manufacturer Narrative

Details for synvisc one received on (b)(6) 2017 batch/lot number: 7rsl021; expiry date: unknown.

Manufacturer Narrative

Details for synvisc one received on (b)(6) 2017.Batch/lot number: 7rsl021; expiry date: unknown.

Event Description

Device malfunction [device malfunction].Increased pain [knee pain] ([condition aggravated]).Knee warm to touch [joint warmth].Knee swollen [swelling of knees].Knee redness [localized erythema].Case narrative: this case is cross referenced with case: (b)(4).This unsolicited case from united states was received on (b)(6) 2017 from a nurse.This case concerns 71 years old female patient who received treatment with synvisc one and later after 3 days had increased pain, knee swollen, knee redness and after unknown latency knee was warm to touch.Also device malfunction was identified for the reported lot number.Medical history included hypercholesterolemia, insomnia, asthma and anemia.Concomitant medications included armodafinil, atorvastatin, escitalopram oxalate (escitalopram), estradiol (estrace), nabumetone, salbutamol sulfate (proair) and ibandronate sodium (boniva).No past drug and concurrent condition were provided.On (b)(6) 2017 the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl019; expiry date: 01-may-2020).On (b)(6) 2017 the patient initiated treatment with intra-articular synvisc one injection once at a dose of 1 df into the left knee for left knee arthritis (batch/lot number: 7rsl021; expiry date: unknown).On the same day, the patient complained of increased pain.The patient was told to rest, ice and elevate and take anti-inflammatory drugs.On (b)(6) 2017 , the patient called and said that she was using crutches.It was reported that the patient had had iced.Also, the patient's knee was swollen and red.On an unknown date in 2017, after unknown latency, the patient's knee was warm to touch.The patient was been taking paracetamol (tylenol) only.She switched to taking naproxen sodium (aleve).Later, on an unknown date in 2017, patient recovered from all events.Corrective treatment: rest, ice and elevate and take anti-inflammatory drugs, paracetamol (tylenol naproxen sodium (aleve), crutches for increased pain; ice for knee warm to touch, unknown for knee swollen and knee redness.Outcome: recovered for all the events.Seriousness crietria: disability for increased pain and device malfunction.A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) for lot number: 7rsl021.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.A pharmaceutical technical complaint (ptc) was initiated for synvisc one with global ptc number:(b)(4) for lot number: 7rsl019.The production and quality control documentation for lot 7rsl019 expiration date (05/2020) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 7rsl019 no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.As of (b)(6) 2018 there were a total of 27 complaints on file for lot 7rsl019: (27) adverse event reports.Sanofi will continue to monitor complaints to determine if a capa is required.Follow up was received on 17-jan-2018.Global ptc number was added.Additional information was received on 09-apr-2018 from nurse.Medical history and comcomitant mediccations added.Patient's demographics (height and weight) added.Additional events of knee swollen and knee redness added with details.Additional dosing regimen with details added.Clinical course updated and text amended accordingly.Additional information was received on 01-jun-2018.Global ptc number and results for lot number 7rsl019 were added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7178142
• MDR Text Key: 97909110
• Report Number: 2246315-2018-00084
• 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: 08/30/2018

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARMODAFINIL (ARMODAFINIL),UNKNOWN; ARMODAFINIL(CON.); ATORVASTATIN (ATORVASTATIN),UNKNOWN; ATORVASTATIN(CON.); BONIVA (IBANDRONATE SODIUM),UNKNOWN; BONIVA(CON.); ESCITALOPRAM (ESCITALOPRAM),UNKNOWN; ESCITALOPRAM(CON.); ESTRACE (ESTRADIOL),UNKNOWN; ESTRACE(CON.); NABUMETONE (NABUMETONE),UNKNOWN; NABUMETONE(CON.); PROAIR(CON.); SALBUTAMOL SULFATE (SALBUTAMOL SULFATE),UNKNOWN
• Patient Outcome(s): Other; Disability
• Patient Age: 71 YR
• Patient Weight: 61