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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)

Event Date 11/09/2017

Event Type  Injury  

Event Description

This case was cross referenced with case: (b)(4).(cluster).This unsolicited case from united states was received on (b)(6) 2017 from health care professional.This case concerns (b)(6) female patient who received treatment with synvisc one and the following day patient had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling 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 the right knee.On (b)(6) 2017, patient had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling and right knee stiffness (latency: 1 day).Patient was given methylprednisolone acetate (depo medrol) injection at the dose of 40 mg.Corrective treatment: methylprednisolone acetate for all outcome: unknown for all events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criterion: required intervention for all pharmacovigilance comment: sanofi company comment dated 15-dec-2017: this case concerns a female patient who received synvisc one injection and later had decreased range of motion, difficulty bearing weight and ambulating.Based upon the information available, the causal role of the product cannot be denied with the occurrence of events.However, there is no information regarding technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.

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 health care professional.This case concerns (b)(6) year old female patient who received treatment with synvisc one and the following day patient had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling 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 the right knee.On (b)(6) 2017, patient had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling and right knee stiffness (latency: 1 day).Patient was given methylprednisolone acetate (depo medrol) injection at the dose of 40 mg.Corrective treatment: methylprednisolone acetate for all 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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: required intervention for all additional information was received on 06-dec-2017 and 02-jan-2018 (processed together with clock start date as 06-dec-2017).Global ptc number was added.Additional event of device malfunction was added with details.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 6-dec-2017: this case concerns a female patient who received synvisc one injection and later had decreased range of motion, difficulty bearing weight and ambulating.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

Decreased range of motion [joint range of motion decreased], device malfunction [device malfunction] , difficulty bearing weight [weight bearing difficulty] , able to do activities of daily living with limitations [activities of daily living impaired], difficulty ambulating [difficulty in walking] , right knee swelling [swelling of r knee] , right knee stiffness [stiff knees] , hyperextension of shoulder [shoulder sprain] , shoulder problem [shoulder discomfort] ([shoulder pain], [tenderness], [joint range of motion decreased]), varicose veins [varicose veins] ([calf pain]), right calf claudication [claudication] , knee aspiration [joint effusion].Case narrative: this case was cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 06-dec-2017 from health care professional.This case concerns 71-year-old female patient who received treatment with synvisc one and the following day patient had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling, right knee stiffness, device malfunction, hyperextension of shoulder, right calf claudication , varicose veins, shoulder problem and able to do activities of daily living with limitations was identified for the reported lot number.(latency: unknown) the patient's past medical history included varicose vein, depression, diabetes mellitus, atrial fibrillation, right rotator cuff surgery in (b)(6) 2017, right calf sclerotherapy in (b)(6) 2016, benign neoplasm of thyroid gland in (b)(6) 2012, stab avuision phlebectomy w/31 incisions on (b)(6) 2012, carpal tunnel release in (b)(6) 2010, foot surgery with (b)(6) 2005 and (b)(6) 2006, appendicectomy in (b)(6) 1992 and atheroscler of native artery of right leg with intermit claudication.Family history included diabetes mellitus with in maternal grand mother, death of father and mother (mother diagnosed with cancer).At the time of the event, the patient had ongoing seasonal allergy, non-tobacco user and peripheral vascular disorder.Patient had no known drug allergy.Concomitant medications included duloxetine hydrochloride (cymbalta); metformin hcl (metformin hcl); acetylsalicylic acid (aspir 81); docosahexaenoic acid, eicosapentaenoic acid, tocopherol (omega 3 [docosahexaenoic acid;eicosapentaenoic acid;tocopherol]); vitamin e nos (vitamin e nos); and rivaroxaban (xarelto).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 the right knee.On (b)(6) 2017, patient had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee stiffness and massive right knee swelling requiring aspiration.Patient was given methylprednisolone acetate (depo medrol) injection at the dose of 40 mg.It was reported that the knee did not improve and ultimately was treated with surgical replacement.On the unknown date of 2018, patient experienced hyperextension of shoulder.Due to which patient experienced shoulder problem.The shoulder problem was identified as specific injury.Symptoms included shoulder pain, tenderness and decreased range of motion.All the symptoms described were moderate in severity and unchanged.Symptoms were relieved by application of ice, restricted activity and non-steroidal anti-inflammatory drugs.The patient was able to do activities of daily living with limitations.Treatment included non-steroidal anti-inflammatory drugs.On (b)(6) 2018, patient had right knee replacement.Since this procedure, patient was unable to walk without developing severe cramping and pain in the right calf that caused her to stop to allow the pain to pass.Corrective treatment: non-steroidal anti-inflammatory drugs for hyperextension of shoulder and shoulder problem methylprednisolone acetate for had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling, right knee stiffness and device malfunction.Outcome: not recovered for shoulder problem; unknown for rest of the 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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: disability for able to do activities of daily living with limitations; required intervention for had decreased range of motion, difficulty bearing weight, difficulty ambulating, right knee swelling and right knee stiffness and device malfunction.Additional information was received on 06-dec-2017 and 02-jan-2018 (processed together with clock start date as 06-dec-2017).Global ptc number was added.Additional event of device malfunction was added with details.Clinical course updated, and text was amended accordingly.Additional information was received on 13-sep-2018 from the non-healthcare professional.Events of hyperextension of shoulder, shoulder problem and able to do activities of daily living with limitations were added.Clinical course updated.Text amended accordingly.Additional information was received on 28-nov-2018 from health care professional.Patient's medical history and concomitant medications were added.Additional event of knee effusion, right calf claudication , varicose veins were added along with details.Corrective treatment aspiration and knee replacement for right knee swelling and right knee stiffness were added.Clinical course updated.Text 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: 7156219
• MDR Text Key: 96111678
• Report Number: 2246315-2017-00280
• 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: 12/27/2018

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: 12/06/2017
• Initial Date FDA Received: 12/30/2017
• Supplement Dates Manufacturer Received: 12/06/2017; 12/06/2017
• Supplement Dates FDA Received: 01/11/2018; 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIR 81 (ACETYLSALICYLIC ACID),TABLET; CYMBALTA (DULOXETINE HYDROCHLORIDE),CAPSULE; METFORMIN HCL (METFORMIN HCL),TABLET; OMEGA 3 [DOCOSAHEXAENOIC ACID,EICOSAPENTAENOIC ACI; VITAMIN E NOS (VITAMIN E NOS),CAPSULE; XARELTO (RIVAROXABAN),UNKNOWN
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 71 YR