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 Capsular Contracture (1761); Loss of Range of Motion (2032); Arthralgia (2355); 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 left knees/ extreme swelling surrounding both knees [swelling of l knee].Pain in left knees/ pain began under the kneecaps [aching (l) knee].Case narrative: this case was cross linked to case (b)(4) (multiple device).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 unknown gender patient who was 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 left knees/ extreme swelling surrounding both knees, pain in left 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), vaccination(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 left knee.On an unknown date in 2021 patient received second injection in left 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).Action taken: unknown for all events.The patient was treated with ibuprofen and cyclobenzaprine for arthralgia and muscle spasms.Corrective treatment was not reported for other events outcome: unknown for all events.A product technical compliant was initiated on 28-sep-2021 with comet compliant id number: (b)(4) and results were pending same.Additional information was received on 28-sep-2021 from the quality department.Strength and formulation added.Global ptc number added.Text amended accordingly.

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 left knees/ extreme swelling surrounding both knees [swelling of l knee] pain in left knees/ pain began under the kneecaps [aching (l) knee] case narrative: this case was cross linked to case (b)(6) 2021 (multiple device) 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 unknown gender patient who was 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 left knees/ extreme swelling surrounding both knees, pain in left 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), vaccination(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 liquid (solution) (3 injection series) (strength: 16 mg/ 2 ml) ( indication , dose, route, frequency, lot: unknown) in left knee.On an unknown date in 2021 patient received second injection in left 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).Action taken: unknown for all events the patient was treated with ibuprofen and cyclobenzaprine for arthralgia and muscle spasms.Corrective treatment was not reported for other events outcome: unknown for all events product technical complaint (ptc) was initiated with global ptc number 100162889 on 28-sep-2021 for product.Batch number; unknown sample status: not available the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance report) 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 required final investigation complete date: 01-nov-2021 with summary code as no assessment possible.Additional information was received on 28-sep-2021 from the quality department.Strength and formulation added.Global ptc number added.Text amended accordingly.Additional information was received on 01-nov-2021 from healthcare professional.Global ptc results, form and strength were added.Text was amended accordingly.

• 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: 12582596
• MDR Text Key: 274942415
• Report Number: 2246315-2021-00163
• 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,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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; CETIRIZINE (CETIRIZINE),UNKNOWN; COLOGEN,UNKNOWN; COLOGEN,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MULTIVITAMIN [VITAMINS NOS] (VITAMINS NOS),UNKNOWN; MULTIVITAMIN [VITAMINS NOS] (VITAMINS NOS),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; VIT D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN; VIT D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN; CETIRIZINE (CETIRIZINE),UNKNOWN; COLOGEN,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MULTIVITAMIN [VITAMINS NOS] (VITAMINS NOS),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; VIT D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN
• Patient Outcome(s): Required Intervention; Other