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

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Hyperextension (4523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Removed 9 ml of fluid from her right knee [joint aspiration].Leg started to hyperextend [limb hyperextension].Leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain [leg pain] ([pain aggravated]).Hears a bit of creaking [joint crepitation].Case narrative: initial information received on 23-jul-2021 from (b)(6) regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) years old female patient who experienced removed 9 ml of fluid from her right knee, leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain and hears a bit of creaking while being treated with 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.At the time of the event, the patient had ongoing arthritis in the knee, polio and thinning of the bone.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection, dose 6 ml total (with an unknown batch number) for osteoarthritis.On an unknown date, after unknown latency, the patient leg started to hyperextend (joint hyperextension) and there was excruciating pain when she straightened it (pain in extremity).The patient felt a little bit of relief and rested for 2-3 days after but started feeling the same thing later in the week.The pain got progressively worse (pain) and then she heard a bit of creaking (joint noise) and felt sharp pain (pain).The medical doctor removed 9 ml of fluid from her right knee (joint aspiration; intervention required).Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain, hears a bit of creaking, removed 9 ml of fluid from her right knee, pain got progressively worse).At time of reporting, the outcome was not recovered / not resolved for all events.

Event Description

Removed 9 ml of fluid from her right knee [joint aspiration], leg started to hyperextend [limb hyperextension], leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain [leg pain] ([pain aggravated]), hears a bit of creaking [joint crepitation].Case narrative: initial information received on 23-jul-2021 from canada regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 80 years old female patient who experienced removed 9 ml of fluid from her right knee, leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain and hears a bit of creaking while being treated with 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.At the time of the event, the patient had ongoing arthritis in the knee, polio and thinning of the bone.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection, liquid (solution) of 48mg/6ml strength at a dose of 6 ml total (with an unknown batch number) for osteoarthritis.On an unknown date, after unknown latency, the patient leg started to hyperextend (joint hyperextension) and there was excruciating pain when she straightened it (pain in extremity).The patient felt a little bit of relief and rested for 2-3 days after but started feeling the same thing later in the week.The pain got progressively worse (pain) and then she heard a bit of creaking (joint noise) and felt sharp pain (pain).The medical doctor removed 9 ml of fluid from her right knee (joint aspiration; intervention required).Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain, hears a bit of creaking, removed 9 ml of fluid from her right knee, pain got progressively worse).At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one.Batch number: unknown; comet compliant id 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 complaints as stated in sop (b)(4) "product event handling" to determine if a capa was required.Final investigation complete date was 04-aug-2021 with summarized conclusion as no assessment possible.Additional information was received on 04-aug-2021 from the other healthcare professional.Global ptc number and ptc results were added.Text amended accordingly.

Event Description

Removed 9 ml of fluid from her right knee [joint aspiration].Leg started to hyperextend [limb hyperextension].Leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain [leg pain] ([pain aggravated]).Hears a bit of creaking [joint crepitation].Case narrative: initial information received on 23-jul-2021 from canada regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 80 years old female patient who experienced removed 9 ml of fluid from her right knee, leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain and hears a bit of creaking while being treated with 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.At the time of the event, the patient had ongoing arthritis in the knee, polio and thinning of the bone.On (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection, liquid (solution) of 48mg/6ml strength at a dose of 6 ml total (with an unknown batch number) for osteoarthritis.On an unknown date, after unknown latency, the patient leg started to hyperextend (joint hyperextension) and there was excruciating pain when she straightened it (pain in extremity).The patient felt a little bit of relief and rested for 2-3 days after but started feeling the same thing later in the week.The pain got progressively worse (pain) and then she heard a bit of creaking (joint noise) and felt sharp pain (pain).The medical doctor removed 9 ml of fluid from her right knee (joint aspiration; intervention required).Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (leg started to hyperextend, leg started to hyperextend and there was excruciating pain when she straightened it/ feels sharp pain, hears a bit of creaking, removed 9 ml of fluid from her right knee, pain got progressively worse).At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one.Batch number: unknown; comet compliant id 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 complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required final investigation complete date was 04-aug-2021 with summarized conclusion as no assessment possible.Additional information was received on 04-aug-2021 from the other healthcare professional.Global ptc number and ptc results were added.Text amended accordingly.Additional information was received on 18-sep-2021 case (b)(4) was identified as duplicate of this case (b)(4) and hence has been prepared for deletion.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: 12257666
• MDR Text Key: 264490798
• Report Number: 2246315-2021-00134
• 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: 09/24/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/09/2021; 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention