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

Lot Number 9RSP017F

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Muscle Spasm(s) (1966); Loss of Range of Motion (2032); Therapeutic Response, Decreased (2271); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 15-dec-2020: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate and experienced allergic reaction to product that included pain and soreness in knee, knee being thick, unable to move or bend the knee, heaviness in the leg, spasm and the product not being effective.Based on the temporal relationship the causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Allergy to the product [allergic reaction] ([aching (r) knee], [heaviness in leg], [joint range of motion decreased], [mobility decreased], [spasms], [swelling of r knee], [device ineffective]) case narrative: initial information from canada received on 11-dec-2020 regarding an unsolicited valid serious case received from the patient via call center.This case is linked to cases 2020sa358075 and 2020sa358195 (same patient for left knee), 2020sa358080 (same patient for injection #1; right knee), 2020sa358096 (same reporter).This case involves an unknown age female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc) and later was allergic to the product the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication included: diuretics.On 26-nov-2020, the patient received hylan g-f 20, sodium hyaluronate (second injection), formulation solution for injection (dose, route, frequency, batch number: unknown) for unknown indication in the right knee.On an unknown date in 2020, after unknown latency, patient experienced soreness and pain (arthralgia), heavy leg (limb discomfort), could not bend her knee (joint range of motion decreased), excessive pain (arthralgia), could not move (mobility decreased), also had spasm (muscle spasm) with no beneficial effect at all (device ineffective).It was reported that her knee was so thick (joint swelling) even after being on diuretics.Patient further reported that her doctor gave her cortisone shot in her knee, but symptoms did not get improved, however, the symptoms got relieved in few days (unknown 2020) later and she could go to work again with limited movement of her knees.Her doctor decided to not give her the 3rd injection because it seemed that she had allergy to the product (hypersensitivity) (onset: 2020 and latency few days).Patient still had the box of the third injection (9rsp017f and expiration date: sep-2022).Action taken: drug withdrawn corrective treatment: cortisone the patient outcome is reported as unknown for hypersensitivity (recovering/resolving for joint range of motion decreased and recovered for other symptoms) a product technical complaint was initiated and the results for the same was pending.

Event Description

Allergy to the product-allergic reaction.Aching (r) knee, heaviness in leg, joint range of motion decreased, mobility decreased, spasms, swelling of r knee, device ineffective.Case narrative: initial information from canada received on 11-dec-2020 regarding an unsolicited valid serious case received from the patient via call center.This case is linked to cases (b)(6) (same patient for left knee), (b)(6) (same patient for injection 1; right knee), (b)(6) (same reporter).This case involves an unknown age female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc) and later was allergic to the product.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication included: diuretics.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate (second injection), formulation solution for injection (dose, route, frequency: unknown) (batch number: 9rsp017f; expiry date: unknown) for unknown indication in the right knee.On an unknown date in 2020, after unknown latency, patient experienced soreness and pain (arthralgia), heavy leg (limb discomfort), could not bend her knee (joint range of motion decreased), excessive pain (arthralgia), could not move (mobility decreased), also had spasm (muscle spasm) with no beneficial effect at all (device ineffective).It was reported that her knee was so thick (joint swelling) even after being on diuretics.Patient further reported that her doctor gave her cortisone shot in her knee, but symptoms did not get improved, however, the symptoms got relieved in few days (unknown 2020) later and she could go to work again with limited movement of her knees.Her doctor decided to not give her the 3rd injection because it seemed that she had allergy to the product (hypersensitivity) (onset: 2020 and latency few days).Patient still had the box of the third injection (9rsp017f and expiration date: sep-2022).Action taken: drug withdrawn.Corrective treatment: cortisone.The patient outcome is reported as unknown for hypersensitivity (recovering/resolving for joint range of motion decreased and recovered for other symptoms).A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc with global ptc number: (b)(4) and the results for the same was pending.Follow up information was received on 22-dec-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information received on 25-dec-2020 from other healthcare professional.Batch number added.Text amended.

Event Description

Allergy to the product [allergic reaction] ([aching (r) knee], [heaviness in leg], [joint range of motion decreased], [mobility decreased], [spasms], [swelling of r knee], [device ineffective]).Case narrative: initial information from canada received on 11-dec-2020 regarding an unsolicited valid serious case received from the patient via call center.This case is linked to cases (b)(4) (same patient for left knee), (b)(4) (same patient for injection 1; right knee), (b)(4) (same reporter).This case involves an unknown age female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc) and later was allergic to the product.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication included: diuretics.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate (second injection), formulation solution for injection (dose, route, frequency: unknown) (batch number: 9rsp017f; expiry date: 30-sep-2022) for unknown indication in the right knee.On an unknown date in 2020, after unknown latency, patient experienced soreness and pain (arthralgia), heavy leg (limb discomfort), could not bend her knee (joint range of motion decreased), excessive pain (arthralgia), could not move (mobility decreased), also had spasm (muscle spasm) with no beneficial effect at all (device ineffective).It was reported that her knee was so thick (joint swelling) even after being on diuretics.Patient further reported that her doctor gave her cortisone shot in her knee, but symptoms did not get improved, however, the symptoms got relieved in few days (unknown 2020) later and she could go to work again with limited movement of her knees.Her doctor decided to not give her the 3rd injection because it seemed that she had allergy to the product (hypersensitivity) (onset: 2020 and latency few days).Patient still had the box of the third injection (9rsp017f and expiration date: sep-2022).Action taken: drug withdrawn.Corrective treatment: cortisone.The patient outcome is reported as unknown for hypersensitivity (recovering/resolving for joint range of motion decreased and recovered for other symptoms).Product technical complaint (ptc) was initiated with global ptc number 100088382 on 11-dec-2020 for product.Batch number: 9rsp017f.Device not returned.The production and quality control documentation for lot: 9rsp017f, expiration date sep-2022 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot: 9rsp017f no capa (corrective and preventive action) is required.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.As of 21dec2020, there is 1 complaint on file for lot#: 9rsp017 and all related sublots.1 complaint is on file for lot#: 9rsp017f: (1) adverse event report.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 27-jan-2021.Follow up information was received on 22-dec-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information received on 25-dec-2020 from other healthcare professional.Batch number added.Text amended.Additional information received on 27-jan-2021 from other healthcare professional.Global ptc results along with expiration date was received.Text amended.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11019114
• MDR Text Key: 226335956
• Report Number: 2246315-2020-00170
• 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,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

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 Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Lot Number: 9RSP017F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/28/2021; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention