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 Edema (1820); Swelling (2091); Burning Sensation (2146); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 29-oct-2020.The case involves a (b)(6) year old female patient who had treatment with synvisc one and had pain in the knee which was most horrible thing ever, as bad as both knee replacements at the same time and for the event patient required intervention with prednisone administration.Based upon the information, the causal role of product cannot be denied with the occurrence of events.However, lack of information regarding concomitant medications, relevant medical history and other risk factors precludes the complete medical case assessment.

Event Description

Pain/most horrible thing ever, as bad as both knee replacements at the same time (left knee) [aching (l) knee], pain limited her mobility and she had to force herself to move [mobility decreased], wheezing [wheezing], lower belly and abdomen swelling [swelling abdomen], fluid (left knee and leg) [leg edema] ([swelling of legs], [burning sensation of lower limb]), fluid (left knee and leg) [effusion (l) knee] ([swelling of l knee]).Case narrative: initial information received from united states on 23-oct-2020 regarding an unsolicited valid serious case received from patient.This case is linked to case (b)(4) (multiple devices for same patient).This case involves a (b)(6) years old female patient who experienced pain/most horrible thing ever, as bad as both knee replacements at the same time (left knee), pain limited her mobility and she had to force herself to move, wheezing, lower belly and abdomen swelling, fluid (left knee and leg) while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, vaccination(s) and family history were not provided.Patient previously had probably 6 injections of hylan g-f 20, sodium hyaluronate with no problems.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, solution for injection at the dose of 6 ml, once via unknown route in left knee (lot: unknown) for no cartilage and arthritis.Information on the batch number was requested.By the next day (on (b)(6) 2020), and for a month thereafter, patient had swelling in left lower legs to just above the knee (peripheral swelling; joint swelling).On an unknown date in 2020, after unknown latency, patient had pain described as most horrible thing ever, as bad as both knee replacements at the same time (arthralgia).It was reported that the pain limited her mobility and she had to force herself to move (mobility decreased; onset: 2020; latency: unknown).Patient had paracetamol (tylenol) which was ineffective and did nothing for the pain.Patient took a prednisone dose pack which helped a little.Event of arthralgia was assessed as serious as intervention required with prednisone treatment.Also, patient had fluid (joint effusion; oedema peripheral) (onset: 2020; latency: unknown) for which she took spironolactone and it did not help with swelling in legs.On an unknown date in 2020, after unknown latency, patient had lower belly and abdomen swelling (abdominal distention) and she also started wheezing.Patient was still using inhalers for the wheezing.Patient continued to have swelling in the legs and a burning feeling due to the swelling (burning sensation).Patient used a wedge pillow to elevate her legs while in bed and she continued to take an anti-inflammatory.The pain was better.Action taken: not applicable for all events.Corrective treatment: paracetamol, prednisone for arthralgia and spironolactone for joint effusion; spironolactone, wedge pillow to elevate her legs and anti-inflammatory for oedema peripheral, unspecified inhaler for wheezing, not reported for rest of the events.Outcome: recovering for arthralgia, unknown for pain limited her mobility and she had to force herself to move, lower belly and abdomen swelling, fluid (left knee and leg) and not recovered for rest of the events.A product technical compliant was initiated and results were pending for the same.

Event Description

Pain/most horrible thing ever, as bad as both knee replacements at the same time (left knee) [aching (l) knee].Pain limited her mobility and she had to force herself to move [mobility decreased].Wheezing [wheezing].Lower belly and abdomen swelling [swelling abdomen].Fluid (left knee and leg) [leg edema] ([swelling of legs], [burning sensation of lower limb]).Fluid (left knee and leg) [effusion (l) knee] ([swelling of l knee]).Case narrative: initial information received from united states on 23-oct-2020 regarding an unsolicited valid serious case received from patient.This case is linked to case (b)(4) (multiple devices for same patient).This case involves a 62 years old female patient who experienced pain/most horrible thing ever, as bad as both knee replacements at the same time (left knee), pain limited her mobility and she had to force herself to move, wheezing, lower belly and abdomen swelling, fluid (left knee and leg) while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, vaccination(s) and family history were not provided.Patient previously had probably 6 injections of hylan g-f 20, sodium hyaluronate with no problems.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, solution for injection at the dose of 6 ml, once via unknown route in left knee (lot: unknown) for no cartilage and arthritis.Information on the batch number was requested.By the next day (on (b)(6) 2020), and for a month thereafter, patient had swelling in left lower legs to just above the knee (peripheral swelling; joint swelling).On an unknown date in 2020, after unknown latency, patient had pain described as most horrible thing ever, as bad as both knee replacements at the same time (arthralgia).It was reported that the pain limited her mobility and she had to force herself to move (mobility decreased; onset: 2020; latency: unknown).Patient had paracetamol (tylenol) which was ineffective and did nothing for the pain.Patient took a prednisone dose pack which helped a little.Event of arthralgia was assessed as serious as intervention required with prednisone treatment.Also, patient had fluid (joint effusion; oedema peripheral) (onset: 2020; latency: unknown) for which she took spironolactone and it did not help with swelling in legs.On an unknown date in 2020, after unknown latency, patient had lower belly and abdomen swelling (abdominal distention) and she also started wheezing.Patient was still using inhalers for the wheezing.Patient continued to have swelling in the legs and a burning feeling due to the swelling (burning sensation).Patient used a wedge pillow to elevate her legs while in bed and she continued to take an anti-inflammatory.The pain was better.Action taken: not applicable for all events.Corrective treatment: paracetamol, prednisone for arthralgia and spironolactone for joint effusion; spironolactone, wedge pillow to elevate her legs and anti-inflammatory for oedema peripheral, unspecified inhaler for wheezing, not reported for rest of the events.Outcome: recovering for arthralgia, unknown for pain limited her mobility and she had to force herself to move, lower belly and abdomen swelling, fluid (left knee and leg) and not recovered for rest of the events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 23-oct-2020 for product.Batch number; unknown.Device not returned.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: 04-nov-2020.Follow up was received on 23-oct-2020 from healthcare professional.Global ptc number was added.Text amended accordingly.Follow up was received on 23-oct-2020 from healthcare professional.Global ptc number was updated.Text amended accordingly.Additional information was received on 04-nov-2020 from healthcare professional.Global ptc results 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: 10754194
• MDR Text Key: 216931901
• Report Number: 2246315-2020-00153
• 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: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention