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 Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544); Decreased Sensitivity (2683); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2021

Event Type  Injury  

Event Description

Cannot lift legs.His wife had to help him to get into the shower [lower extremity dysfunction].Feel cold then hot [feeling hot and cold].Pain felt/pain feel when about to crack knee [knee pain].Case narrative: initial information received on 19-apr-2021 from (b)(6) regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) year old male patient who experienced cannot lift legs, feel cold then hot and pain felt/pain feel when about to crack knee while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (solution for injection) (dosage, batch number, frequency, route: unknown).On the unknown date of (b)(6) 2021, after the latency for some days of starting the treatment of hylan g-f 20, sodium hyaluronate, he felt different pain that she had before injection, the pain he felt was the pain one feel when knee about to crack (arthralgia).He could not left legs (musculoskeletal disorder) (disability) (latency: some days).His wife had to help him to get into the shower.He had pain attacks that last 15-20 minutes.On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, he felt cold then hot (feeling of body temperature change) and took paracetamol.Action taken: not applicable.Corrective treatment: paracetamol (tylenol) for arthralgia; not reported for rest all the events.Outcome: unknown for all the events.

Event Description

Cannot lift legs.His wife had to help him to get into the shower [lower extremity dysfunction] feel cold then hot [feeling hot and cold] pain felt/pain feel when about to crack knee [knee pain].Case narrative: initial information was received on 19-apr-2021 from canada regarding an unsolicited valid serious case from a patient.This case involves a 76 years old male patient who experienced cannot lift legs, feel cold then hot and pain felt/pain feel when about to crack knee while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021 the patient started using hylan g-f 20, sodium hyaluronate, (solution for injection) (dosage, batch number, frequency, route: unknown).On the unknown date of apr-2021, after the latency for some days of starting the treatment of hylan g-f 20, sodium hyaluronate, he felt different pain that she had before injection, the pain he felt was the pain one feel when knee about to crack (arthralgia).He could not left legs (musculoskeletal disorder) (disability) (latency: some days).His wife had to help him to get into the shower.He had pain attacks that last 15-20 minutes.On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, he felt cold then hot (feeling of body temperature change) and took paracetamol.As of 11-may-2021, lot number of hylan g-f 20, sodium hyaluronate was unknown.Action taken: not applicable.Corrective treatment: paracetamol (tylenol) for arthralgia; not reported for rest all the events.Outcome: unknown for all the events.Product technical complaint (ptc) was initiated with global ptc number 100119204 on 19-apr-2021 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: 24-may-2021.Additional information was received on 19-apr-2021 from other healthcare professional.Gptc number was added.Additional information was received on 11-may-2021 from physician.Information about unknown lot number of hylan g-f 20, sodium hyaluronate was added.Additional information was received on 24-may-2021 from healthcare professional.Global ptc results and number added.Text was amended accordingly.

Event Description

Cannot lift legs.His wife had to help him to get into the shower [lower extremity dysfunction].Feel cold then hot [feeling hot and cold].Pain felt/pain feel when about to crack knee [knee pain].Case narrative: initial information was received on 19-apr-2021 from canada regarding an unsolicited valid serious case from a patient.This case involves a 76 years old male patient who experienced cannot lift legs, feel cold then hot and pain felt/pain feel when about to crack knee while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (solution for injection) (dosage, batch number, frequency, route: unknown).On the unknown date of (b)(6) 2021, after the latency for some days of starting the treatment of hylan g-f 20, sodium hyaluronate, he felt different pain that she had before injection, the pain he felt was the pain one feel when knee about to crack (arthralgia).He could not left legs (musculoskeletal disorder) (disability) (latency: some days).His wife had to help him to get into the shower.He had pain attacks that last 15-20 minutes.On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, he felt cold then hot (feeling of body temperature change) and took paracetamol.As of 11-may-2021, lot number of hylan g-f 20, sodium hyaluronate was unknown.Action taken: not applicable.Corrective treatment: paracetamol (tylenol) for arthralgia; not reported for rest all the events.Outcome: unknown for all the events.Product technical complaint (ptc) was initiated with global ptc number 100119204 on 19-apr-2021 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: 24-may-2021.Additional information was received on 19-apr-2021 from other healthcare professional.Gptc number was added.Additional information was received on 11-may-2021 from physician.Information about unknown lot number of hylan g-f 20, sodium hyaluronate was added.Additional information was received on 24-may-2021 from healthcare professional.Global ptc results and number added.Text was amended accordingly.Follow up was received on 28-may-2021 from healthcare professional.The complaint (b)(4) has been reopened due to incomplete complaint information.No significant information was received.Based on the information received on 24-may-2021, the incident characterization was updated to reportable side effect from blank.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11714359
• MDR Text Key: 262882574
• Report Number: 2246315-2021-00093
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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): Disability