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 Erythema (1840); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 29-nov-2017 from a non-healthcare professional.This case concerns a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had pain, swelling and warmth in both knees.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 6 ml (batch/lot number: 7rsl021; expiry date: 31-may- 2020) (indication: unknown) into bilateral knees.On an unknown date in 2017, the patient experienced pain, swelling and warmth in both the knees.The doctor was made aware of this and recommended that the patient come in for evaluation.It was reported that the patient lives over 1.5 hours from the office and did not come into the office until (b)(6) 2017.The doctor attempted to drain the knees and was not able to aspirate fluid from the knees.It was reported that the doctor injected cortisone in the knees at that time.Corrective treatment: cortisone for all the events.Outcome: unknown for all the events.Seriousness criteria: required intervention for all the events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.

Event Description

Upon internal review on 11-dec-2017 from the pharmacist and this case became medically confirmed.This unsolicited case from united states was received on 29-nov-2017 from pharmacist.This case concerns a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had pain, swelling and warmth in both knees; 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 6 ml (batch/lot number: 7rsl021; expiry date: 31-may- 2020) (indication: unknown) into bilateral knees.On an unknown date in 2017, the patient experienced pain, swelling and warmth in both the knees.The doctor was made aware of this and recommended that the patient come in for evaluation.It was reported that the patient lives over 1.5 hours from the office and did not come into the office until (b)(6) 2017.The doctor attempted to drain the knees and was not able to aspirate fluid from the knees.It was reported that the doctor injected cortisone in the knees at that time.Corrective treatment: cortisone for pain, swelling and warmth in both knees outcome: unknown for all.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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for all.Additional information was received on 11-dec-2017 and 17-dec-2017 (processed together with clock start date of 11-dec-2017) from pharmacist.Product start date was updated.An additional event of device malfunction was added with details.Clinical course was updated.Global ptc number was added.Text was amended accordingly.Upon internal review on 11-dec-2017, the case became medically confirmed.Pharmacovigilance comment: sanofi company comment for follow up dated 12-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later had pain in both knees, swelling of knees, and joint warmth.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out 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

Upon internal review on 11-dec-2017 from the pharmacist and this case became medically confirmed.This unsolicited case from united states was received on 29-nov-2017 from pharmacist.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after 1 day had erythema, pain in both knees/pain, discomfort, attempted to aspirate both knees, swelling in both knees/swelling, after unknown latency had warmth in both knees; also, device malfunction was identified for the reported lot number.No concurrent condition was provided.The patient had past treatment with synvisc one (on (b)(6) 2017; received with no noted problems).The patient's medical history included (b)(6), hypertension, arthritis and clostridiumdifficle.The patient had no known drug allergy.The patient's concomitant medications included: acetylsalicylic acid (asa), calcium, colecalciferol (vitamin d3), cyanocobalamin (vitamin b12) and buspirone.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml (packaged syringe administered) (batch/lot number: 7rsl021; expiry date: 31-may-2020) for osteoarthritis into bilateral knees.After receiving the injection, the patient was notified that this batch/lot was recalled due to increased reactions.On (b)(6) 2017 (latency 1 day), the patient experienced pain, swelling in both knees, erythema (less than 12 hours) and discomfort.The patient denied appointment.The doctor attempted to drain the knees and cortisone was injected into both knees.The fluid was obtained from right knee and sent for labs.It was reported that the patient lives over 1.5 hours from the office and did not come into the office until (b)(6) 2017.The same day the patient reported to office with discomfort and erythema.On the same day, aerobic blood fluid culture test was done which showed no growth at 4 to 5days and also gram stain showed rare wbc with no microorganisms.On an unknown date in 2017, the patient had warmth in both the knees.It was reported that there was no disease or medication that might have played a role in patient's events.Corrective treatment: cortisone for erythema, pain in both knees/pain, swelling in both knees/swelling, warmth in both knees, discomfort and attempted to aspirate both knees; outcome: unknown for warmth in both knees and device malfunction; recovered for attempted to aspirate both knees, discomfort, swelling in both knees/swelling, pain in both knees/pain, erythema a pharmaceutical technical complaint (ptc) was initiated with (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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for all reporter causality assessment: the events of pain, swelling and erythema were related with synvisc one.Additional information was received on 11-dec-2017 and 17-dec-2017 (processed together with clock start date of 11-dec-2017) from pharmacist.Product start date was updated.An additional event of device malfunction was added with details.Clinical course was updated.Global ptc number was added.Text was amended accordingly.Upon internal review on 11-dec-2017, the case became medically confirmed.Follow up information was received on 17-dec-2017.No new information received.Additional information was received on 28-dec-2017 from the nurse.The patient's demographic details including age and gender was added.The additional events of erythema, discomfort and attempted to aspirate both knees were added with details.The event verbatim was updated from "pain in both knees" to "pain in both knees/pain" and from "swelling in both knees" to "swelling in both knees/swelling".The suspect product indication was added.The event onset date of device malfunction, pain in both knees/pain, swelling in both knees/swelling was updated from 2017 to 28-nov-2017.The outcome of the events of pain in both knees/pain, swelling in both knees/swelling was updated from unknown to recovered.The patient's medical history, concomitant medication and past medication was added.The laboratory tests of aerobic blood fluid culture test and gram stain were added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later had erythema, pain in both knees, swelling of knees, and joint warmth.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out 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: 7108266
• MDR Text Key: 94510833
• Report Number: 2246315-2017-00232
• 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,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2017

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: Health Professional
• 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: 11/29/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 12/28/2017
• Supplement Dates FDA Received: 12/30/2017; 01/11/2018
• Patient Sequence Number: 1
• Treatment: ASA(CON.); BUSPIRONE(CON.); CALCIUM(CON.); SYNVISC ONE(PREV.) - START; SYNVISC ONE(PREV.) - STOP UNKNOWN; VITAMIN B12(CON.); VITAMIN D3(CON.)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72