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)

Patient Problems Arthralgia (2355); Joint Swelling (2356)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

This case was cross referenced with case: (b)(4).This unsolicited case from united states was received on 06-dec-2017 from other non-health care professional this case concerns (b)(6) female patient who received treatment with synvisc one and later after few days patient had right knee pain, right knee swelling, weight bearing difficulty and right knee stiffness no medical history, past drugs, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021, expiry date: 31- may-2020) for osteoarthritis in right knee.On an unknown date in (b)(6) 2017, after few days of receiving injection, patient returned with right knee pain, swelling, stiffness, difficulty bearing weight.Patient was given methylprednisolone acetate 40mg injection and an out of work note.Corrective treatment: methylprednisolone acetate (depo-medrol) for right knee pain and right knee swelling; not reported for rest events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criterion: required intervention for right knee pain and right knee swelling.

Event Description

This case was cross referenced with case: (b)(4).This unsolicited case from united states was received on 06-dec-2017 from other non-health care professional this case concerns (b)(6) year old female patient who received treatment with synvisc one and later after few days patient had right knee pain, right knee swelling, weight bearing difficulty and right knee stiffness.Also, device malfunction was identified for the reported lot number.No medical history, past drugs, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021, expiry date: 31- may-2020) for osteoarthritis in right knee.On an unknown date in (b)(6) 2017, after few days of receiving injection, patient returned with right knee pain, swelling, stiffness, difficulty bearing weight.Patient was given methylprednisolone acetate 40mg injection and an out of work note.Corrective treatment: methylprednisolone acetate (depo-medrol) for right knee pain and right knee swelling; not reported for rest events outcome: unknown 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: required intervention for right knee pain, device malfunction and right knee swelling additional information was received on 06-dec-2017 and 02-jan-2018 (both information processed together with clock stat date of 06-dec-2017).Event of device malfunction was added.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly pharmacovigilance comment: sanofi company comment for follow up dated 06-dec-2017: this case concerns a female patient who received synvisc one injection from the recalled lot and had right knee swelling, stiffness, pain and weight bearing difficulty.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 referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 06-dec-2017 from other non-health care professional this case concerns (b)(6) year old female patient who received treatment with synvisc one and the same day patient had right knee pain, right knee swelling, weight bearing difficulty and right knee stiffness.Also, device malfunction was identified for the reported lot number.No past drug was provided.Medical history included diabetes, cancer, heart disease and hypertension.Patient had no known drug allergy (nkda).Concomitant medications included meloxicam, lisinopril/ hydrochlorothiazide, atorvastatin and solifenacin succinate (velicare).On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl021, expiry date: 31- may-2020) for osteoarthritis in right knee.The same day, the patient returned with right knee pain, swelling, stiffness, difficulty bearing weight.Patient was given methylprednisolone acetate 40mg injection and an out of work note.Corrective treatment: methylprednisolone acetate (depo-medrol) for right knee pain and right knee swelling; not reported for rest events outcome: recovered 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.Reporter causality: related for knee pain, swelling, stiffness, difficulty bearing weight seriousness criterion: required intervention for right knee pain, device malfunction and right knee swelling additional information was received on 06-dec-2017 and 02-jan-2018 (both information processed together with clock stat date of 06-dec-2017).Event of device malfunction was added.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 06-feb-2018.Medical history and concomitant medication were added.Event outcome was updated for all the events along with onset dates.Reporter causality was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 06-feb-2018: the follow up information did not change the previous case assessment.This case concerns a female patient who received synvisc one injection from the recalled lot and had right knee swelling, stiffness, pain and weight bearing difficulty.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: 7156220
• MDR Text Key: 96112456
• Report Number: 2246315-2017-00281
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 12/06/2017; 02/06/2018
• Supplement Dates FDA Received: 01/11/2018; 02/16/2018
• Patient Sequence Number: 1
• Treatment: MELOXICAM(CON.)
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR