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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment on 11-jan-2022: this case involves adult female patient who experienced couldn't stand up, had cramps and must be allergic while being treated with hylan g-f 20, sodium hyaluronate (synvisc).Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Cramps, couldn't stand up, (difficulty in standing).Must be allergic (allergic reaction to drug) (burning sensation), (arthralgia aggravated).Case narrative: initial information received on (b)(6) 2022 from (b)(6) regarding an unsolicited valid serious case received from a patient.This case involves adult female patient who experienced couldn't stand up, had cramps and must be allergic while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included knee pain.The patient's past medical treatment(s) included cortisone injection, that the patient used for 2 years, every 4 to 5 months.The patient's past vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate [synvisc] (strength, form, dosage, frequency, route, batch number, expiration date and indication: unknown).The patient's doctor decided to start the medication and 1 day later unfortunately, an incredible pain went through the patient's knee, a burning like there were 20 needles in the patient's knee (burning sensation), cramps (muscle spasms),the patient could not stand up (dysstasia), it was unbearable but the patient endured it for 24 hrs and mentioned that it was so much more painful than the knee pain the patient had before calling the doctor urgently, who gave him a shot of cortisone to relieve the pain and mentioned that may be the patient was allergic (drug hypersensitivity).First time product used : yes.Action taken was not applicable.The patient was treated with cortisone for all the events.At time of reporting, the outcome was unknown for all the events.

Event Description

Cramps [cramps], couldn't stand up [difficulty in standing] , must be allergic [allergic reaction to drug] ([burning sensation], [arthralgia aggravated]), case narrative: initial information received on 04-jan-2022 from canada regarding an unsolicited valid serious case received from a patient.This case involves adult female patient who experienced couldn't stand up, had cramps and must be allergic while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included knee pain.The patient's past medical treatment(s) included cortisone injection, that the patient used for 2 years, every 4 to 5 months.The patient's past vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate [synvisc] (strength, form, dosage, frequency, route, batch number, expiration date and indication: unknown).The patient's doctor decided to start the medication and 1 day later unfortunately, an incredible pain went through the patient's knee, a burning like there were 20 needles in the patient's knee (burning sensation), cramps (muscle spasms),the patient could not stand up (dysstasia), it was unbearable but the patient endured it for 24 hrs and mentioned that it was so much more painful than the knee pain the patient had before calling the doctor urgently, who gave him a shot of cortisone to relieve the pain and mentioned that may be the patient was allergic (drug hypersensitivity).First time product used : yes.Action taken was not applicable.The patient was treated with cortisone for all the events.At time of reporting, the outcome was unknown for all the events.Upon on internal review, (b)(4) (to be deleted) was identified to be duplicate of (b)(4), (to be retained).Hence, all the information from the (b)(4), (to be deleted) has to be merged in the (b)(4), prepared for deletion.

Manufacturer Narrative

Sanofi company comment on (b)(6) 2022: this case involves adult female patient who experienced couldn't stand up, had cramps and must be allergic while being treated with hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

• 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: 13262023
• MDR Text Key: 288298061
• Report Number: 2246315-2022-00001
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female