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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 10-may-2021: this case concerns a female patient who was on treatment with synvisc one and reported she can't drive because it is her right knee that is so painful and had effusion in knee.It was reported that healthcare professional did not aspirate or remove synovial fluid or effusion prior to administration of synvisc one as recommended, which can contribute to knee effusion leading to pain and impaired driving ability.Also patient¿s underlying condition of osteoarthritis can be confounding factor as well.Further, detailed information regarding other medications, medical history would aid in comprehensive assessment of the case.

Event Description

Can't drive because it is her right knee that is so painful [impaired driving ability].Effusion [injection site joint effusion] ([injection site joint pain], [injection site joint swelling], [wrong technique in device usage process], [injection site joint discomfort]).Cannot walk or bear weight [weight bearing difficulty].Cannot walk or bear weight [unable to walk].Case narrative: initial information received from united states on 30-apr-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) years old female patient who can't drive because it is her right knee that is so painful, had effusion, cannot walk or bear weight with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The case is linked to (b)(4) (multiple devices for same patient: previous left knee injection).The patient's past medical history, vaccination(s) and family history were not provided.Concomitant medications included anti-inflammatory otc (over the counter).Patient had used synvisc one over the years with good results, and a couple of years ago, she received synvisc one in her left knee.On (b)(6) 2021, the patient received synvisc one solution for injection (strength 8mg/ml) at the dose of 48 mg once in right knee via unknown route (lot - unknown) for osteoarthritis (oa).There will be no information available on the batch number for this case.It was reported that her hcp (healthcare professional) did not aspirate or remove synovial fluid or effusion prior to administration (wrong technique in device usage process, latency: same day).During that evening and the next day, the right knee did not swell, although it was sore, and it didn't feel right (injection site joint pain, injection site joint discomfort; latency: same day).On (b)(6) 2021, patient had synvisc one injected into her left knee.Patient stated her left knee was fine, but the right knee was all swollen like her left one was the last time (injection site joint swelling, onset: (b)(6) 2021, latency: 2 day).She states that it was massively swollen and it hurts like hell, just sitting here with the knee elevated and ice packs on it.Patient wanted the effusion removed immediately (injection site joint effusion, onset: (b)(6) 2021, latency: unknown), because it was so painful but her doctor says that she has to wait for 2 weeks before she can have the effusion removed.Patient also worried that putting ice packs on the knee will make the synvisc one "harden" in her knee.Patient was concerned because she cannot walk or bear weight (gait inability, weight bearing difficulty) and she can't drive because it was her right knee that was so painful (impaired driving ability) (onset: (b)(6) 2021, latency: unknown).Events of injection site joint effusion (along with the symptoms) and impaired driving ability were assessed as serious as they were leading to disability.Patient had a nerve ablation scheduled for (b)(6) 2021, also has an appointment for a dental implant that she cannot miss.Action taken: not applicable for all events.Corrective treatment: ice and elevation for injection site joint effusion, not reported for rest of the events at time of reporting, the outcome was unknown for all events.A product technical complaint was initiated and results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 26-aug-2021: this case concerns a female patient who was on treatment with synvisc one and reported she can't drive because it is her right knee that is so painful and had effusion in knee.It was reported that healthcare professional did not aspirate or remove synovial fluid or effusion prior to administration of synvisc one as recommended, which can contribute to knee effusion leading to pain and impaired driving ability.Also patient¿s underlying condition of osteoarthritis can be cofounding factor as well.Further, detailed information regarding other medications, medical history would aid in comprehensive assessment of the case.

Event Description

Can't drive because it is her right knee that is so painful [impaired driving ability].Effusion [injection site joint effusion] ([injection site joint pain], [injection site joint swelling], [wrong technique in device usage process], [injection site joint discomfort]) cannot walk or bear weight [weight bearing difficulty].Cannot walk or bear weight [unable to walk].Case narrative: initial information received from united states on 30-apr-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 64 years old female patient who can't drive because it is her right knee that is so painful, had effusion, cannot walk or bear weight with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The case is linked to (b)(4) (multiple devices for same patient: previous left knee injection).The patient's past medical history, vaccination(s) and family history were not provided.Concomitant medications included anti-inflammatory otc (over the counter).Patient had used synvisc one over the years with good results, and a couple of years ago, she received synvisc one in her left knee.On (b)(6) 2021, the patient received synvisc one injection liquid (solution) (strength 48 mg/ 6 ml) at the dose of 48 mg once in right knee via unknown route (lot - unknown) for osteoarthritis (oa).There will be no information available on the batch number for this case.It was reported that her hcp (healthcare professional) did not aspirate or remove synovial fluid or effusion prior to administration (wrong technique in device usage process, latency: same day).During that evening and the next day, the right knee did not swell, although it was sore, and it didn't feel right (injection site joint pain, injection site joint discomfort; latency: same day).On (b)(6) 2021, patient had synvisc one injected into her left knee.Patient stated her left knee was fine, but the right knee was all swollen like her left one was the last time (injection site joint swelling, onset: (b)(6) 2021, latency: 2 day).She states that it was massively swollen and it hurts like hell, just sitting here with the knee elevated and ice packs on it.Patient wanted the effusion removed immediately (injection site joint effusion, onset: (b)(6) 2021, latency: unknown), because it was so painful but her doctor says that she has to wait for 2 weeks before she can have the effusion removed.Patient also worried that putting ice packs on the knee will make the synvisc one "harden" in her knee.Patient was concerned because she cannot walk or bear weight (gait inability, weight bearing difficulty) and she can't drive because it was her right knee that was so painful (impaired driving ability) (onset: (b)(6) 2021, latency: unknown).Events of injection site joint effusion (along with the symptoms) and impaired driving ability were assessed as serious as they were leading to disability.Patient had a nerve ablation scheduled for (b)(6) 2021, also has an appointment for a dental implant that she cannot miss.Action taken: not applicable for all events.Corrective treatment: ice and elevation for injection site joint effusion, not reported for rest of the events.At time of reporting, the outcome was unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 30-apr-2021 for product synvisc one with unknown batch number.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: 26-aug-2021 with summary code as no assessment possible.Follow up information received on 30-apr-2021 from other healthcare professional.Global ptc number added.Formulation and strength updated.Text amended.Additional information was received on 26-aug-2021 from healthcare professional.Global ptc results were added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11796067
• MDR Text Key: 264761599
• Report Number: 2246315-2021-00100
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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: Health Professional
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR