MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ

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

Patient Problems Loss of Range of Motion (2032); Arthralgia (2355); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Unable to bend [joint range of motion decreased] unable to stand [difficulty in standing] muscle spasms [muscle spasms] knees were unable to support to walk [unable to walk] severe swelling [swelling of l knee] pain in both knees [aching (l) knee]. Case narrative: this case was cross linked with case: (b)(4) (multiple devices, 2nd injection). Initial information received on 28-sep-2021 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference number: mw5102783. This case involves patient of unknown demographics who experienced knees were unable to support to walk, unable to stand, muscle spasms, severe swelling,unable to bend and pain in both knees while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included levothyroxine (levothyroxine); losartan (losartan); spironolactone (spironolactone); cetirizine hydrochloride (cetrizine); vitamin d (vitamin d nos); multivitamin (vitamin nos) and chlorphenamine maleate, paracetamol, phenylpropanolamine hydrochloride (cologen). On the unknown date of 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, batch number, route, indication, frequency: unknown) in left knee. On the unknown date of 2021, after the latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced severe swelling (joint swelling) and pain in left knee (arthralgia), unable to support to walk (gait inability), unable to stand (dysstasia) and muscle spasms (muscle spasm). Patient had elevated iced and but patient was unable to bend (joint range of motion decreased). The pain began under the knee caps seven hours after the injections and continued to extreme swelling surrounding both the knees. Patient took ibuprofen and cyclobenzaprine. Action taken: unknown for all the events. Corrective treatment: ibuprofen and cyclobenzaprine for muscle spasms and arthralgia; not reported for rest all the events outcome: unknown for all the events. Seriousness criteria: medically significant and intervention required for all events a product technical compliant was initiated and results were pending same.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12573219
• MDR Text Key: 282045698
• Report Number: 2246315-2021-00161
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/04/2021 Patient Sequence Number: 1

Treatment

CETRIZINE (CETIRIZINE HYDROCHLORIDE),UNKNOWN; CETRIZINE (CETIRIZINE HYDROCHLORIDE),UNKNOWN; COLOGEN,UNKNOWN; COLOGEN,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MULTIVITAMIN [VITAMINS NOS],UNKNOWN; MULTIVITAMIN [VITAMINS NOS],UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN; VITAMIN D [VITAMIN D NOS],UNKNOWN