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

Lot Number 9RSP011Z

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

Patient Problems Inflammation (1932); Loss of Range of Motion (2032); Joint Disorder (2373)

Event Date 08/18/2020

Event Type  Injury  

Event Description

Difficulties in the daily functioning [activities of daily living impaired], accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint [injection site joint inflammation], ([synovial fluid analysis abnormal], [injection site joint swelling], [injection site joint effusion], [injection site joint pain]) lack of possibility of straightening of the knee and full bending of the joint [joint range of motion decreased].Case narrative: based on additional information received on 07-sep-2020 from a patient, this case initially processed as non-serious was upgraded to serious because event of difficulties in the daily functioning was added which was assessed to cause disability to the patient.Also, previously captured event of 'accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint' was updated to serious as intervention was required for the same.This case was linked to case (b)(4) (multiple devices for same patient).Initial information was received from (b)(6) on 26-aug-2020 regarding an unsolicited valid serious case from a pharmacist.This case involves a (b)(6) years old male patient who experienced difficulties in the daily functioning; accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint (injection site joint inflammation); and lack of possibility of straightening of the knee and full bending of the joint, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical history included knee arthroscopy and arthrodesis of tibiofibular joint in (b)(6) 2020.The patient's past medical treatment(s), vaccination(s) and family history, concomitant medications were not provided.On (b)(6) 2020, the patient received the first injection of synvisc series.On (b)(6) 2020, the patient reported to a pre-appointed visit to a physician in order to receive the second dose, before which a considerable amount of unclear fluid was drained.The physician suggested that it might be a problem with the product.Despite that, the patient received the second dose in order to confirm if something might be wrong with the product.On (b)(6) 2020, the patient had second hylan g-f 20, sodium hyaluronate injection at dose of 2 ml (lot - 9rsp011z, expiration date: 31-may-2022) in the knee for increasing of mobility in the joint and reducing the feeling of heaviness in the joint after training (route and frequency: unknown).The patient was recommended for limitation of walking for 1-2 days and cold compresses.Radioisotope synovectomy was recommended in case of recurrence of exudative fluid.On same day, after 4 hours of injection, the knee got so intensely swollen (injection site joint swelling) that the patient reported the injection in the afternoon mentioning about accumulation of fluid which indicated acute inflammatory state (injection site joint inflammation) (injection site joint effusion).On the consecutive day, orthopedist's consultation was performed ((b)(6) 2020), the patient was found to have joint effusion (knee oedema) (recurrent).On same day, 1 day after receiving hylan g-f 20, sodium hyaluronate injection, upon physical examination, puncture of left knee was done again, and 48 ml of slight bloody synovial fluid was removed (synovial fluid analysis abnormal).Reportedly, betamethasone dipropionate, betamethasone sodium phosphate (diprophos), 1 ampoule was administered.The event of injection site joint inflammation was assessed as serious as intervention was required for the same.The patient was recommended for limitation of walking for 1-2 days and cold compresses.Radioisotope synovectomy of the left knee was recommended following consultations, physicians, orthopaedists suggested complaining about the product.It was unknown whether it might be a defective batch or improper storage during transportation.In patient's opinion the product was administered with a precision, correctly and in the appropriate timing.As of (b)(6) 2020, the patient had lack of possibility of straightening of the knee and full bending of the joint (latency: few days; joint range of motion decreased), persisting inflammation state of the synovial membrane- fluid in the joint, pain (injection site joint pain) and oedema of the joint and difficulties in the daily functioning (latency: few days; loss of personal independence in daily activities).The event of difficulties in the daily functioning was assessed to cause disability to the patient.Action taken: drug withdrawn for all the events.Corrective treatment: betamethasone dipropionate, betamethasone sodium phosphate (diprophos) for injection site joint inflammation; not reported for rest both events.Outcome: not recovered/not resolved for all the events.A product technical complaint (ptc) was initiated for synvisc with global ptc number 100063800 and results were pending for the same.Follow up information was received on 31-aug-2020 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on 07-sep-2020 from a patient.Case was upgraded to serious.Events- difficulties in the daily functioning (serious with disability); and lack of possibility of straightening of the knee and full bending of the joint were added.As reported term was updated to accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint for injection site joint inflammation, its outcome, corrective treatment and seriousness (due to intervention required) was updated.Additional symptoms- puncture of left knee- 48 ml of slight bloody synovial fluid (synovial fluid analysis abnormal) and pain and oedema of the joint (injection site joint pain) were added for injection site joint inflammation.Previously captured symptom- knee oedema (peripheral swelling) was merged with another previously captured symptom-injection site joint effusion.Suspect product dose and indication were added.Clinical course was updated, and text was amended accordingly.

Event Description

Difficulties in the daily functioning [activities of daily living impaired], accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint [injection site joint inflammation] ([synovial fluid analysis abnormal], [injection site joint swelling], [injection site joint effusion], [injection site joint pain]), and lack of possibility of straightening of the knee and full bending of the joint [joint range of motion decreased].Case narrative: based on additional information received on 07-sep-2020 from a patient, this case initially processed as non-serious was upgraded to serious because event of difficulties in the daily functioning was added which was assessed to cause disability to the patient.Also, previously captured event of 'accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint' was updated to serious as intervention was required for the same.This case was linked to case (b)(4) (multiple devices for same patient).Initial information was received from poland on 26-aug-2020 regarding an unsolicited valid serious case from a pharmacist.This case involves a 30 years old male patient who experienced difficulties in the daily functioning; accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint (injection site joint inflammation); and lack of possibility of straightening of the knee and full bending of the joint, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical history included knee arthroscopy and arthrodesis of tibiofibular joint in (b)(6) 2020.The patient's past medical treatment(s), vaccination(s) and family history, concomitant medications were not provided.On (b)(6) 2020, the patient received the first injection of synvisc series.On (b)(6) 2020, the patient reported to a pre-appointed visit to a physician in order to receive the second dose, before which a considerable amount of unclear fluid was drained.The physician suggested that it might be a problem with the product.Despite that, the patient received the second dose in order to confirm if something might be wrong with the product.On (b)(6) 2020, the patient had second hylan g-f 20, sodium hyaluronate injection at dose of 2 ml (lot - 9rsp011z, expiration date: 31-may-2022) in the knee for increasing of mobility in the joint and reducing the feeling of heaviness in the joint after training (route and frequency: unknown).The patient was recommended for limitation of walking for 1-2 days and cold compresses.Radioisotope synovectomy was recommended in case of recurrence of exudative fluid.On same day, after 4 hours of injection, the knee got so intensely swollen (injection site joint swelling) that the patient reported the injection in the afternoon mentioning about accumulation of fluid which indicated acute inflammatory state (injection site joint inflammation) (injection site joint effusion).On the consecutive day, orthopedist's consultation was performed ((b)(6) 2020), the patient was found to have joint effusion (knee oedema) (recurrent).On same day, 1 day after receiving hylan g-f 20, sodium hyaluronate injection, upon physical examination, puncture of left knee was done again, and 48 ml of slight bloody synovial fluid was removed (synovial fluid analysis abnormal).Reportedly, betamethasone dipropionate, betamethasone sodium phosphate (diprophos), 1 ampoule was administered.The event of injection site joint inflammation was assessed as serious as intervention was required for the same.The patient was recommended for limitation of walking for 1-2 days and cold compresses.Radioisotope synovectomy of the left knee was recommended following consultations, physicians, orthopaedists suggested complaining about the product.It was unknown whether it might be a defective batch or improper storage during transportation.In patient's opinion the product was administered with a precision, correctly and in the appropriate timing.As of(b)(6) 2020, the patient had lack of possibility of straightening of the knee and full bending of the joint (latency: few days; joint range of motion decreased), persisting inflammation state of the synovial membrane- fluid in the joint, pain (injection site joint pain) and oedema of the joint and difficulties in the daily functioning (latency: few days; loss of personal independence in daily activities).The event of difficulties in the daily functioning was assessed to cause disability to the patient.Action taken: drug withdrawn for all the events.Corrective treatment: betamethasone dipropionate, betamethasone sodium phosphate (diprophos) for injection site joint inflammation; not reported for rest both events.Outcome: not recovered/not resolved for all the events.A product technical complaint (ptc) was initiated on 20-aug-2020 for synvisc (lot number 9rsp011z ) with global ptc number (b)(4).The production and quality control documentation for lot # 9rsp011z expiration date (2022-05) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 9rsp011z no capa was required.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.As of 01-sep-2020 there were 2 complaints on file for lot# 9rsp011z and all related sublots.2 complaints were on file for lot# 9rsp011z: (2) adverse event reports.The pv review was completed on sep.1st and no safety signal was identified.Sanofi will continue to monitor complaints to determine if a capa was required.Final investigation was completed on 24-sep-2020.Follow up information was received on 31-aug-2020 from other healthcare professional.Global ptc number added.No significant information was received.Additional information was received on 07-sep-2020 from a patient.Case was upgraded to serious.Events- difficulties in the daily functioning (serious with disability); and lack of possibility of straightening of the knee and full bending of the joint were added.As reported term was updated to accumulation of fluid indicated acute inflammatory state/persisting inflammation state of the synovial membrane- fluid in the joint for injection site joint inflammation, its outcome, corrective treatment and seriousness (due to intervention required) was updated.Additional symptoms- puncture of left knee- 48 ml of slight bloody synovial fluid (synovial fluid analysis abnormal) and pain and oedema of the joint (injection site joint pain) were added for injection site joint inflammation.Previously captured symptom- knee oedema (peripheral swelling) was merged with another previously captured symptom-injection site joint effusion.Suspect product dose and indication were added.Clinical course was updated, and text was amended accordingly.Additional information was received on 24-sep-2020 from other healthcare professional.Ptc results received and processed.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10526162
• MDR Text Key: 213853194
• Report Number: 2246315-2020-00132
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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: Health Professional
• Device Expiration Date: 05/31/2022
• Device Lot Number: 9RSP011Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR