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 Loss of Range of Motion (2032); Arthralgia (2355); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Peripheral Edema (4578)

Event Date 01/01/2021

Event Type  Injury  

Event Description

If sitting i was unable to stand [difficulty in standing].Were unable to bend or support standing, walking and getting up from a sitting position [joint range of motion decreased].Muscle spasms [muscle spasms].Knees were unable to support me to walk [unable to walk].Severe swelling and pain in left knee/ pain began under the knee caps [injection site joint pain].Severe swelling in left knee/ extreme swelling surrounding both knees [injection site joint swelling].Case narrative: initial information was received from consumer/non-hcp on 28-sep-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5102783.The case was cross linked with case: (b)(4).This case involves an adult patient of an unknown gender who had severe swelling in left knee/ extreme swelling surrounding both knees , knees were unable to support the patient to walk, if sitting was unable to stand, severe swelling and pain in left knee/ pain began under the knee caps, were unable to bend or support standing, walking and getting up from a sitting position and muscle spasms while being treated with 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 nos (vit d); vitamins nos (multivitamins); and chlorphenamine maleate, paracetamol, phenylpropanolamine hydrochloride (cologen).On an unknown date in 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection strength 16mg/2ml, (dosage, route, frequency, batch number, expiry date, indication: unknown).The information regarding lot number was requested.This is 3 injection series and the patient received 3rd injection in left knee and experienced severe swelling and pain in both knees (injection site joint swelling, injection site joint pain) occurred and the knees were unable to support me to walk (gait inability), if sitting i was unable to stand (dysstasia).The pain began under the knee caps 7 hr after the injections and continued to extreme swelling surrounding both knees and they were unable to bend or support standing, walking and getting up from a sitting position (joint range of motion decreased).The patient elevated iced and took ibuprofen and cyclobenzaprine for the pain and muscle spasms but neither of those medication eliminated the pain, swelling or muscle spasms.The pain score was a 10 plus.No testing was done.These events were assessed as medically significant.Action taken: not applicable for all events.Corrective treatment: the patient was treated with ibuprofen and cyclobenzaprine for injection site joint pain and muscle spasms; not reported for rest of the events.At time of reporting, the outcome was unknown for all events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available.Ptc sated: 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 (nonconformance performance) 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 to determine if a capa is required.The final investigation was completed on 01-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 01-aug-2023 from healthcare professional (quality department).Ptc results along with strength were added.Text 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: 17479676
• MDR Text Key: 320662342
• Report Number: 2246315-2023-00087
• 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: 08/08/2023

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2023
• 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): Other; Required Intervention