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

Lot Number UNKNOWN

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

Patient Problems Arthralgia (2355); Ambulation Difficulties (2544); Balance Problems (4401); 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 or support standing [joint range of motion decreased], unable to stand/ unable to bend or support standing/ unable to getting up from a sitting position [difficulty in standing], muscle spasms [muscle spasms], unable to walking [unable to walk], severe swelling in right knees/ extreme swelling surrounding both knees [swelling of knees], pain in right knees/ pain began under the kneecaps [aching (r) knee].Case narrative: this case was cross linked to the cases (b)(4), (multiple devices used in same patient).Initial information received on 28-sep-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5102783 via patient.This case involves an unknown age and gender patient who experienced unable to bend or support standing, unable to stand/ unable to bend or support standing/ unable to getting up from a sitting position, unable to walking, severe swelling in right knees/ extreme swelling surrounding both knees, pain in right knees/ pain began under the kneecaps and muscle spasms 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), concomitant(s) and family history were not provided.Concomitant medications included levothyroxine; losartan; spironolactone; cetirizine; vitamin d not otherwise specified (nos); vitamins nos (multivitamins); and chlorphenamine maleate, paracetamol, phenylpropanolamine hydrochloride (cologen).In 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (3 injection series) (strength :16 mg/2 ml) (indication , dose, route, frequency, lot: unknown) in right knee.On an unknown date in 2021 patient received second injection in right knee.On the day of second injection, the pain began under the kneecaps 7 hours after the injection (arthralgia) and continued to extreme swelling surrounding both knees (joint swelling) (latency: few days).The patient was unable to bend or support standing (joint range of motion decreased, dysstasia), walking (gait inability) and getting up from a sitting position (onset: 2021; latency: few days).Patient elevated iced and took ibuprofen and cyclobenzaprine for the pain and muscle spasms (onset: 2021; latency: unknown) but neither of those medication eliminated the pain, swelling or muscle spasms.The pain score was a 10 plus.No testing was done.All the events were believed to have caused serious injury (seriousness: medically significant for all, intervention required for joint range of motion decreased).Action taken: unknown for all events.The patient was treated with icing, elevation, ibuprofen and cyclobenzaprine for arthralgia and muscle spasms.Corrective treatment was not reported for other events.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 30-sep-2021 for " synvisc" (lot/batch number and expiry date: unknown) with global ptc number: (b)(4).Sample status: not received.Ptc states: complaint: the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 has not indicated any safety issue.Sanofi will continue to monitor complaints."product event handling" to determine if a capa (corrective and preventive action) is required.Final investigation complete date: 06-oct-2021 the summarized conclusion for this case is no assessment possible.The complaint (b)(4) for usa (united states of america) has been reopened for the following reason: wrong complaint information.Additional information was received on 06-oct-2021 from the quality department.Ptc details and strength were added.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 17469044
• MDR Text Key: 320481931
• Report Number: 2246315-2023-00086
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: CETIRIZINE (CETIRIZINE),UNKNOWN; COLOGEN,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MULTIVITAMINS [VITAMINS NOS] (VITAMINS NOS),UNKNOW; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; VIT D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN
• Patient Outcome(s): Required Intervention; Other