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

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

Patient Problems Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/12/2021

Event Type  Injury  

Event Description

Must use a walker because she is very handicapped after [walker user].Pain for 2-3 days after the injection but the recovery time is getting longer and longer [injection site pain].Synvisc-one injections administered in her left hip [product administered at inappropriate site].Case narrative: initial information received on 22-feb-2021 regarding an unsolicited valid serious case received from a patient from (b)(6).This case is cross referred with cases (b)(4), (b)(4) and (b)(4) (multiple devices, same patient).This case involves a (b)(6) years old female patient who received hylan g-f 20, sodium hyaluronate (synvisc one) and must use a walker because she is very handicapped after, pain for 2-3 days after the injection but the recovery time is getting longer and longer, patient received synvisc one injection in left hip.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection (fourth injection), at a dose of 6 ml, once (route and lot - unknown) in left hip (product administered at inappropriate site) for osteoarthritis of the hip.The patient or healthcare staff related factors that contributed to this error in outpatient setting.Information on batch number was requested.On the same day, patient only experienced pain for 2-3 days after the injection but the recovery time was getting longer and longer (injection site pain).There was no inflammation, but patient must use a walker because she was very handicapped after (walking aid user, onset date: 2020 and latency: unknown).Patient felt wonderful once she recovered.Patient wanted to know if this was normal, difference between synvisc and synvisc-one, how long were they supposed to last and what was the average recovery time.First time product used: no, still using product: no, was device used : yes.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.Outcome: recovered for injection site pain and walking aid user, not applicable for other event.Seriousness criteria: disability for walking aid user.A product technical complaint was initiated with results pending for the same.

Event Description

Difficulty walking which can last about three or four days [walking difficulty] lot of pain approximately 30 minutes after receiving the injection which spreads to the ankle [radiating pain] pain for 2-3 days after the injection but the recovery time is getting longer and longer [injection site joint pain] ([product administered at inappropriate site]) case narrative: initial information received on 22-feb-2021 regarding an unsolicited valid serious case received from a patient from canada.This case is cross referred with cases (b)(4) (multiple devices, same patient).This case involves a 48 years old female patient who received hylan g-f 20, sodium hyaluronate (synvisc one) and had difficulty walking which can last about three or four days, pain for 2-3 days after the injection but the recovery time is getting longer and longer and lot of pain approximately 30 minutes after receiving the injection which spreads to the ankle.Patient had previously used hylan g-f 20, sodium hyaluronate.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection (fourth injection), at a dose of 6 ml, once (route and lot - unknown) in left hip (product administered at inappropriate site) for osteoarthritis of the hip.The patient or healthcare staff related factors that contributed to this error in outpatient setting.Information on batch number was requested.On the same day, patient only experienced pain for 2-3 days after the injection but the recovery time was getting longer and longer (injection site joint pain).Patient said she was in a lot of pain approximately 30 minutes after receiving the injection which spread to the ankle (pain; onset: (b)(6) 2021; latency: 30 min).She had difficulty walking which could last about three or four days (gait disturbance; onset: (b)(6) 2021, latency: same day).The patient must use a walker to move around.There was no inflammation, but patient must use a walker because she was very handicapped after.Patient felt wonderful once she recovered.Patient wanted to know if this was normal, difference between synvisc and synvisc-one, how long were they supposed to last and what was the average recovery time.Patient also mentioned that her last injection took longer for the pain to stop and the difficultly walking to return to normal.Event of gait disturbance was assessed as serious due to disability.Action taken: not applicable for all events corrective treatment: walker for gait disturbance; not reported for rest of the events outcome: recovered all events seriousness criteria: disability for walking aid user a product technical complaint (ptc) was initiated on 22-feb-2021 with results pending for the same with global ptc number (b)(4).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 is identified and mitigated through the ncr 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.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation was completed on 11-mar-2021.Follow up information was received on 22-feb-2021 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on 22-feb-2021 from patient.Event of lot of pain approximately 30 minutes after receiving the injection which spreads to the ankle was added with details.Verbatim updated for event from must use a walker because she is very handicapped after to difficulty walking which can last about three or four days.Clinical course updated.Text amended accordingly.Additional information was received on 11-mar-2021 from other healthcare professional.Ptc results received and processed.Text amended accordingly.

Event Description

Difficulty walking which can last about three or four days [walking difficulty] lot of pain approximately 30 minutes after receiving the injection which spreads to the ankle [radiating pain] pain for 2-3 days after the injection but the recovery time is getting longer and longer [injection site joint pain] ([product administered at inappropriate site]) case narrative: initial information received on 22-feb-2021 regarding an unsolicited valid serious case received from a patient from canada.This case is cross referred with cases (b)(4) (multiple devices, same patient).This case involves a 48 years old female patient who received hylan g-f 20, sodium hyaluronate (synvisc one) and had difficulty walking which can last about three or four days, pain for 2-3 days after the injection but the recovery time is getting longer and longer and lot of pain approximately 30 minutes after receiving the injection which spreads to the ankle.Patient had previously used hylan g-f 20, sodium hyaluronate.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection (fourth injection), at a dose of 6 ml, once (route and lot - unknown) in left hip (product administered at inappropriate site) for osteoarthritis of the hip.The patient or healthcare staff related factors that contributed to this error in outpatient setting.Information on batch number was requested.On the same day, patient only experienced pain for 2-3 days after the injection but the recovery time was getting longer and longer (injection site joint pain).Patient said she was in a lot of pain approximately 30 minutes after receiving the injection which spread to the ankle (pain; onset: (b)(6) 2021; latency: 30 min).She had difficulty walking which could last about three or four days (gait disturbance; onset: (b)(6)b2021, latency: same day).The patient must use a walker to move around.There was no inflammation, but patient must use a walker because she was very handicapped after.Patient felt wonderful once she recovered.Patient wanted to know if this was normal, difference between synvisc and synvisc-one, how long were they supposed to last and what was the average recovery time.Patient also mentioned that her last injection took longer for the pain to stop and the difficultly walking to return to normal.Event of gait disturbance was assessed as serious due to disability.Action taken: not applicable for all events corrective treatment: walker for gait disturbance; not reported for rest of the events outcome: recovered all events seriousness criteria: disability for walking aid user a product technical complaint (ptc) was initiated with results pending for the same with global ptc number 100104766.Follow up information was received on 22-feb-2021 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on 22-feb-2021 from patient.Event of lot of pain approximately 30 minutes after receiving the injection which spreads to the ankle was added with details.Verbatim updated for event from must use a walker because she is very handicapped after to difficulty walking which can last about three or four days.Clinical course updated.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: 11391288
• MDR Text Key: 234017427
• Report Number: 2246315-2021-00079
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability