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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Arthralgia (2355)

Event Type  Injury  

Event Description

Right knee pain worse than the left knee pain/ pain at its worst is 10/10 [knee pain] ([condition worsened]).Calcaneal fracture from a broken heel spur [bone spur fracture].Case narrative: this case was cross linked with case id ((b)(4)) same patient.Initial information received on 17-sep-2018 regarding an unsolicited valid serious case received from a health care professional from united states.This case involves a (b)(6) female patient who experienced right knee pain worse than the left knee pain/ pain at its worst is 10/10, while she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included obesity from (b)(6) 2014 to (b)(6) 2015 with morbid obesity with bmi of 45.0-49.9, adult, back pain, varicose vein, carpal tunnel decompression, gastrectomy, hernia repair, hysterectomy, tendon sheath incision, cardiac disorder and renal failure.Patient was allergic to penicillin (nausea) and latex, natural rubber (rash).The patient's family history included diabetes mellitus with father.At the time of the event, the patient had ongoing somnolence on (b)(6) 2014, gastrooesophageal reflux disease on (b)(6) 2014, metabolic surgery on (b)(6) 2015, obesity on (b)(6) 2015, arthritis on (b)(6) 2015, knee deformity on (b)(6) 2015, arthralgia on (b)(6) 2015, arthritis on (b)(6) 2015, osteoarthritis on (b)(6) 2016, rubber sensitivity, drug hypersensitivity with reaction- nausea, muscular weakness, musculoskeletal stiffness, joint effusion, crepitations with in both knees and knee deformity.The patient's past vaccination(s) was not provided.Concomitant medications included sildenafil citrate (integra [sildenafil citrate]); biotin (biotin); calcium citrate (calcium citrate); omega-3 fatty acids;vitamin e nos (omega-3 fatty acids;vitamin e nos); vitamin b complex (b complex [vitamin b complex]); cyanocobalamin (cyanocobalamin); fluticasone (fluticasone); meloxicam (mobicam [meloxicam]); omeprazole (prilosec [omeprazole]); polyethylene glycol (polyethylene glycol); salbutamol sulfate (proair hfa); bupivacaine (bupivacaine); and triamcinolone acetonide (triamcinolone acetonide).On (b)(6) 2016, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate), injection, 6 ml via intra-articular route for osteoarthritis.On an unknown date, "the" had right knee pain worse than the left knee pain/ pain at its worst is 10/10 (arthralgia) following hylan g-f 20 and sodium hyaluronate.On an unknown date, patient had been unable to exercise due to a calcaneal fracture from a broken heel spur.The patient had surgery scheduled in (b)(6) on her foot and presented in a walking boot.The patient was requesting a steroid injection in bilateral knees.Relevant laboratory test results included: x-ray limb - on (b)(6) 2017: (knee pain, unspecified chronicity, unspecified laterality).Final diagnosis was right knee pain worse than the left knee pain/ pain at its worst is 10/10 and calcaneal fracture from a broken heel spur.Corrective treatment- ibuprofen (advil), triamcinolone acetonide (kenalog) and bupivacaine (marcaine).Outcome- unknown for both the events.Seriousness criteria- intervention required for right knee pain worse than the left knee pain/ pain at its worst is 10/10.Follow up information received on 02-oct-2018 from lawyer.No new information received.A product technical complaint was initiated on 11-oct-2018 for synvisc one, batch number: unknown, global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses 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.Sanofi will continue to monitor adverse events to determine if a capa is still required.Additional information was received on 11-oct-2018.Global ptc number was received and ptc details were added.Follow up information was received on 11-oct-2018.No new information was received.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8005698
• MDR Text Key: 125034683
• Report Number: 2246315-2018-00690
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

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?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: B COMPLEX [VITAMIN B COMPLEX] (VITAMIN B COMPLEX),; BIOTIN (BIOTIN),; BUPIVACAINE (BUPIVACAINE),; CALCIUM CITRATE (CALCIUM CITRATE),; CYANOCOBALAMIN (CYANOCOBALAMIN),; FLUTICASONE (FLUTICASONE),; INTEGRA [SILDENAFIL CITRATE] (SILDENAFIL CITRATE),; MOBICAM [MELOXICAM] (MELOXICAM),; OMEGA-3 FATTY ACIDS,VITAMIN E NOS (OMEGA-3 FATTY A; POLYETHYLENE GLYCOL (POLYETHYLENE GLYCOL),; PRILOSEC [OMEPRAZOLE] (OMEPRAZOLE),; PROAIR HFA (SALBUTAMOL SULFATE),; TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE),
• Patient Outcome(s): Other; Required Intervention