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

Lot Number UNKNOWN

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

Patient Problems Arthritis (1723); Muscle Weakness (1967); Arthralgia (2355); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The injections stopped working because her knees were too far gone [osteoarthritis aggravated] four months in another hospital to get the strength back in her legs to have knee replacements [lower extremities weakness of] not able to walk for three days after having the injections/unable to walk altogether [unable to walk] didn't get her out of bed for long periods of time [mobility decreased] the injections stopped working [device ineffective] case narrative: this case is linked to case id (b)(4) (multiple device suspect used for the same patient) initial information was received from (b)(6) on (b)(6) 2022 regarding an unsolicited valid serious case from a patient this case involves 70 years old female patient who reported that the injections stopped working because her knees were too far gone, four months in another hospital to get the strength back in her legs to have knee replacements, not able to walk for three days after having the injections/unable to walk altogether and didn't get her out of bed for long periods of time while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had synvisc as well as synvisc-one injections in the past in both knees for osteoarthritis.The patient had no medical history, concomitant disease, or risk factor.In 2017, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection at dose of 2 ml via intra-articular route in right knee (with an unknown batch number, expiry date, strength, frequency) for osteoarthritis.Information on batch number was requested.On an unknown date, she was not able to walk for three days after having the injections (gait inability, caused disability, required hospitalization).Shortly after that the patient ended up in the hospital with a medical emergency, they didn't get her out of bed for long periods of time (mobility decreased, caused disability; hospitalization prolonged) (if they got her out of bed once a week that was it and was in the hospital for a couple of months) and she was unable to walk altogether.Then four months in another hospital to get the strength back in her legs to have knee replacements (muscular weakness, required hospitalization) and then back to have physiotherapy after the replacements.On an unknown date, after unknown latency, the injections stopped working for her (device ineffective) and was not able to get them anymore so she had her knees replaced.According to her, the injections stopped working because her knees were too far gone (osteoarthritis, required intervention).Patient did not like kneeling since getting the knee replacement as it felt awful.It was unknown if the patient experienced any additional symptoms/events.There were no lab data/results available.Action taken: not applicable for all the events corrective treatment: knee replacements for the injections stopped working because her knees were too far gone); physiotherapy for muscular weakness; not reported for rest all events at time of reporting, the outcome was unknown for the event the injections stopped working because her knees were too far gone and device ineffective; recovered for rest all events a product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this case involves 70 years old female patient who reported that the injections stopped working because her knees were too far gone, four months in another hospital to get the strength back in her legs to have knee replacements, not able to walk for three days after having the injections/unable to walk altogether and didn't get her out of bed for long periods of time while being treated with hylan g-f 20, sodium hyaluronate [synvisc] for osteoarthritis.Based on the available information, causal relationship between the events and suspect product could not be denied.However, aggravation of underlying condition of osteoarthritis is the major confounding factor for the occurrence of reported events.Also, further information regarding patient¿s past medications, concomitant medications, post-injection routine, knee status at injection start date, injection technique, and other risk factors would aid in better case assessment.

Event Description

The injections stopped working because her knees were too far gone [osteoarthritis aggravated] four months in another hospital to get the strength back in her legs to have knee replacements [lower extremities weakness of] not able to walk for three days after having the injections/unable to walk altogether [unable to walk] didn't get her out of bed for long periods of time [mobility decreased] the injections stopped working [device ineffective] case narrative: this case is linked to case id (b)(6) (multiple device suspect used for the same patient) initial information was received from canada on 07-dec-2022 regarding an unsolicited valid serious case from a patient this case involves 70 years old female patient who reported that the injections stopped working because her knees were too far gone, four months in another hospital to get the strength back in her legs to have knee replacements, not able to walk for three days after having the injections/unable to walk altogether and didn't get her out of bed for long periods of time while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had synvisc as well as synvisc-one injections in the past in both knees for osteoarthritis.The patient had no medical history, concomitant disease, or risk factor.In 2017, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection at dose of 2 ml via intra-articular route in right knee having the strength 16mg/2ml (with an unknown batch number, expiry date, frequency) for osteoarthritis.Information on batch number was requested.On an unknown date, she was not able to walk for three days after having the injections (gait inability, caused disability, required hospitalization).Shortly after that the patient ended up in the hospital with a medical emergency, they didn't get her out of bed for long periods of time (mobility decreased, caused disability; hospitalization prolonged) (if they got her out of bed once a week that was it and was in the hospital for a couple of months) and she was unable to walk altogether.Then four months in another hospital to get the strength back in her legs to have knee replacements (muscular weakness, required hospitalization) and then back to have physiotherapy after the replacements.On an unknown date, after unknown latency, the injections stopped working for her (device ineffective) and was not able to get them anymore so she had her knees replaced.According to her, the injections stopped working because her knees were too far gone (osteoarthritis, required intervention).Patient did not like kneeling since getting the knee replacement as it felt awful.It was unknown if the patient experienced any additional symptoms/events.There were no lab data/results available.Action taken: not applicable for all the events corrective treatment: knee replacements for the injections stopped working because her knees were too far gone); physiotherapy for muscular weakness; not reported for rest all events at time of reporting, the outcome was unknown for the event the injections stopped working because her knees were too far gone and device ineffective; recovered for rest all events a product technical complaint (ptc) was initiated on 06-dec-2022 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available and the ptc stated: complaint: adverse event.Based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.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.Defect class has been updated to ii.- (dp 09-dec-22).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa 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) process.Sanofi will continue to monitor complaints and trending to determine if a capa (corrective and preventive action) was required.Re opened as the product was changed from synvisc one to synvisc product tab updated - (dp 12-jan-23).The final investigation was completed on 17-jan-2023 with summarized conclusion as no assessment possible.Additional information was received on 06-jan-2023 from healthcare professional (quality department).Ptc number was added.Text amended accordingly.Additional information was received on 17-jan-2023 from the quality department.Ptc details and strength was added.

• 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: 15969757
• MDR Text Key: 305361334
• Report Number: 2246315-2022-00152
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization; Disability
• Patient Sex: Female