MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; 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); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) company comment dated (b)(6) 2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but was unable to bend the knee, had difficulty putting weight on the knee, pain in left knee and swelling in left knee.Based on the temporal relationship, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Inability to bend the knee [joint range of motion decreased].Difficulty putting weight on the knee [weight bearing difficulty].Pain in left knee [aching (l) knee].Swelling in left knee [swelling of l knee].Case narrative: initial information from united states received on 15-dec-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.This case involves (b)(6) years old female patient who reported inability to bend the knee, difficulty putting weight on the knee, pain in left knee and swelling in left knee while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included meniscal surgery in the knee, several injections of corticosteroid into the knee, and an injury to the right knee.Patient also mentioned that she had been treating her behcet's disease with colchicine for 30 years.The patient's past medical treatment included (b)(6)covid-19 vaccine in (b)(6) 2021.The patient's past vaccination(s) and family history were not provided.Concomitant medications included colchicine for behcet's disease.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate solution for injection (strength: 48 mg) at a dose of 48 mg once for osteoarthritis (lot and route: unknown) with a 21 g needle in left knee.The reporter stated that the left knee felt good at first, after the injection, but then about 24 hours later (on (b)(6) 2021; latency: 1 day), the patient began to experience, in the left knee, pain (arthralgia), swelling (joint swelling), and an inability to bend the knee (joint range of notion decreased), and difficulty putting weight on the knee (weight bearing difficulty), but no fever.All the events were assessed as serious as intervention was required for the events.Patient had started a course of a medrol dose pack, and she did use ice on the knee, and now was using heat on the knee, and stated that the knee had improved some from its worst point.Patient stated that for 4 days she was not able to bend the left knee at all, but that now she was able to bend her knee to about a 90-degree angle, but cannot bent it any more than that, and it was still swollen and painful, and still difficult to put weight on the left knee.Action taken: not applicable for all events the patient was treated with methylprednisolone (medrol) for all events.At time of reporting, the outcome was recovering / resolving for all events.

Manufacturer Narrative

Sanofi company comment dated 24-dec-2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but was unable to bend the knee, had difficulty putting weight on the knee, pain in left knee and swelling in left knee.Based on the temporal relationship, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Inability to bend the knee [joint range of motion decreased].Difficulty putting weight on the knee [weight bearing difficulty].Pain in left knee [aching (l) knee].Swelling in left knee [swelling of l knee].Case narrative: initial information from united states received on 15-dec-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.This case involves 75 years old female patient who reported inability to bend the knee, difficulty putting weight on the knee, pain in left knee and swelling in left knee while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included meniscal surgery in the knee, several injections of corticosteroid into the knee, and an injury to the right knee.Patient also mentioned that she had been treating her behcet's disease with colchicine for 30 years.The patient's past medical treatment included moderna covid-19 vaccine in (b)(6) 2021.The patient's past vaccination(s) and family history were not provided.Concomitant medications included colchicine for behcet's disease.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection liquid solution (strength: 48 mg/ 6 ml) at a dose of 48 mg once for osteoarthritis (lot and route: unknown) with a 21 g needle in left knee.The reporter stated that the left knee felt good at first, after the injection, but then about 24 hours later (on (b)(6) 2021; latency: 1 day), the patient began to experience, in the left knee, pain (arthralgia), swelling (joint swelling), and an inability to bend the knee (joint range of notion decreased), and difficulty putting weight on the knee (weight bearing difficulty), but no fever.All the events were assessed as serious as intervention was required for the events.Patient had started a course of a medrol dose pack, and she did use ice on the knee, and now was using heat on the knee, and stated that the knee had improved some from its worst point.Patient stated that for 4 days she was not able to bend the left knee at all, but that now she was able to bend her knee to about a 90-degree angle, but cannot bent it any more than that, and it was still swollen and painful, and still difficult to put weight on the left knee.Action taken: not applicable for all events.The patient was treated with methylprednisolone (medrol) for all events.At time of reporting, the outcome was recovering / resolving for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 15-dec-2021 for product synvisc.Batch number; unknown; sample status: not available 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 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 has not indicated any safety issue.The final investigation was completed on 06-jan-2022 with summarized conclusion as no assessment possible.Follow up information was received on 15-dec-2021 from healthcare professional.Global ptc number, added.Text was amended accordingly.Additional information was received on 06-jan-2022 from other health professional.Ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 13085058
• MDR Text Key: 288280193
• Report Number: 2246315-2021-00182
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• 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
• Treatment: COLCHICINE (COLCHICINE),UNKNOWN; COLCHICINE (COLCHICINE),UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female