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

Lot Number ARSP013

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

Patient Problems Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Left knee pain [aching (l) knee], left knee swelling [swelling of l knee], drained fluid off the knee [joint effusion], drained fluid off the knee [arthrocentesis].Case narrative: initial information received on (b)(6) 2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) female patient who experienced left knee pain, left knee swelling and drained fluid off the knee with the use of medical device hylan g-f 20, sodium hyaluronate synvisc.The patient's past medical history, medical treatment's, vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, formulation, batch number, route, indication frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced left knee pain arthralgia, left knee swelling joint swelling)and drained fluid off the knee (joint effusion) (arthrocentesis).The drainage was a cloudy fluid with little blood.Action taken: drug withdrawn for all the events.It was not reported if the patient received a corrective treatment for the events left knee pain, left knee swelling, drained fluid off the knee.Outcome: unknown for all the events.

Event Description

Drained fluid off the knee [injection site joint effusion].Drained fluid off the knee [arthrocentesis].Drainage was a cloudy fluid with little blood [synovial fluid red blood cells].Drainage was a cloudy fluid with little blood [synovial fluid analysis abnormal].Left knee swelling [injection site joint swelling].Left knee pain [injection site joint pain].Case narrative: initial information received on 24-mar-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp(health care professional).This case involves a 78 years old female patient who experienced drained fluid off the knee, drainage was a cloudy fluid with little blood, left knee swelling and left knee pain with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (16 mg/2ml), (batch number, route, indication frequency: unknown).Information for batch number requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced left knee pain (injection site joint pain), left knee swelling (injection site joint swelling) and drained fluid off the knee (injection site joint effusion, arthrocentesis, both required medical intervention).Reportedly, the patient received second time in left knee.She went home experienced pain and swelling.She went back to hcp (healthcare professional), and they drained fluid off the knee.The drainage was a cloudy fluid with little blood (synovial fluid analysis abnormal, synovial fluid red blood cells).Consumer wanted to report the issue.Hcp discontinued the product.She would not get third injection.There was no further information for this report.Action taken: drug withdrawn for all the events.Corrective treatment: fluid drained for injection site joint effusion, not reported for rest of events.Outcome: unknown for all the events.A product technical compliant (ptc) was initiated on (b)(6) 2022 for synvisc (lot - unknown) with global ptc number (b)(4) and results were pending for the same.The sample status of the ptc (product technical complaint) was requested and awaited.Additional information was received on 24-mar-2022 from other healthcare professional.Gptc number and strength was added.Clinical course of event was added.Upon internal review, event added-drainage was a cloudy fluid with little blood.Lab data added.

Event Description

Drained fluid off the knee/aspirated 70 ml of fluid from the knee [injection site joint effusion].Drained fluid off the knee/aspirated 70 ml of fluid from the knee [arthrocentesis].Drainage was a cloudy fluid with little blood [synovial fluid red blood cells].Drainage was a cloudy fluid with little blood [synovial fluid analysis abnormal].Knee joint space narrowing [joint space narrowing].Bone density loss [bone density decreased].Left knee swelling [injection site joint swelling].Left knee pain [injection site joint pain].Case narrative: initial information was received on 24-mar-2022 from united states regarding an unsolicited valid serious case received from a patient.This case involves a 79 years old female patient who reported drained fluid off the knee/aspirated 70 ml of fluid from the knee, drainage was a cloudy fluid with little blood, left knee swelling, left knee pain, bone density loss and knee joint space narrowing after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient had first visit with health-care professional.On (b)(6) 2022, the patient received first injection of (hylan g-f 20, sodium hyaluronate) synvisc series (16 mg/2ml), (batch number: arsp013; expiry date: unknown) (route, indication frequency: unknown).On (b)(6) 2022, the patient received second injection of (hylan g-f 20, sodium hyaluronate) synvisc series (16 mg/2ml) in left knee (batch number: arsp013; expiry date: unknown) (route, indication frequency: unknown).On (b)(6) 2022 (after second injection), after latency of 7 days after starting the treatment with hylan g-f 20, sodium hyaluronate and on same day after last dose, patient went home experienced left knee pain (injection site joint pain), and left knee swelling (injection site joint swelling).She then had a reaction and was seen on (b)(6) 2022 for pain and swelling.On (b)(6) 2022, 8 days after starting treatment, she went back to hcp (healthcare professional), and they drained fluid off (aspirated) 70 ml of fluid from the knee (injection site joint effusion, arthrocentesis, both required medical intervention) and the pain continued.The drainage was a cloudy fluid with little blood (synovial fluid analysis abnormal, synovial fluid red blood cells, latency: 8 days).Consumer wanted to report the issue.Hcp discontinued the product.She would not get third injection.She was still in pain and had imaging done.It was recommended that she follow-up with ortho.The report showed knee joint space narrowing (joint space narrowing, latency: unknown), and bone density loss (bone density decreased, latency: unknown).Action taken: drug withdrawn for all the events.Corrective treatment: fluid drained for injection site joint effusion, not reported for rest of events.Outcome: not recovered for the event left knee pain, unknown for rest of all the events.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc (lot - unknown) with global ptc number (b)(4).The sample status of the ptc (product technical complaint) was not available.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.The final investigation was completed on (b)(6) 2022 with summarized conclusion as no assessment possible.Additional information was received on 24-mar-2022 from other healthcare professional.Gptc number and strength was added.Clinical course of event was added.Upon internal review, event added- drainage was a cloudy fluid with little blood.Lab data added.Additional information was received on 03-may-2022 from a patient.Synvisc injection dates added.Batch number was added.Events added- bone density loss and knee joint space narrowing.Outcome of left knee pain was updated.Clinical course was updated.Text was amended accordingly.Additional information was received on 16-jun-2022 from other healthcare professional.Global ptc results were added.Text was amended accordingly.

Event Description

Drained fluid off the knee/aspirated 70 ml of fluid from the knee [injection site joint effusion] drained fluid off the knee/aspirated 70 ml of fluid from the knee [arthrocentesis] drainage was a cloudy fluid with little blood [synovial fluid red blood cells] drainage was a cloudy fluid with little blood [synovial fluid analysis abnormal] knee joint space narrowing [joint space narrowing] bone density loss [bone density decreased] left knee swelling [injection site joint swelling] left knee pain [injection site joint pain] case narrative: initial information was received on 24-mar-2022 from united states regarding an unsolicited valid serious case received from a patient.This case involves a 79 years old female patient who reported drained fluid off the knee/aspirated 70 ml of fluid from the knee, drainage was a cloudy fluid with little blood, left knee swelling, left knee pain, bone density loss and knee joint space narrowing after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient had first visit with health-care professional.On (b)(6) 2022, the patient received first injection of (hylan g-f 20, sodium hyaluronate) synvisc series (16 mg/2ml), (batch number: arsp013; expiry date: unknown) (route, indication frequency: unknown).On (b)(6) 2022, the patient received second injection of (hylan g-f 20, sodium hyaluronate) synvisc series (16 mg/2ml) in left knee (batch number: arsp013; expiry date: unknown) (route, indication frequency: unknown).On (b)(6) 2022 (after second injection), after latency of 7 days after starting the treatment with hylan g-f 20, sodium hyaluronate and on same day after last dose, patient went home experienced left knee pain (injection site joint pain), and left knee swelling (injection site joint swelling).She then had a reaction and was seen on (b)(6) 2022 for pain and swelling.On (b)(6) 2022, 8 days after starting treatment, she went back to hcp (healthcare professional), and they drained fluid off (aspirated) 70 ml of fluid from the knee (injection site joint effusion, arthrocentesis, both required medical intervention) and the pain continued.The drainage was a cloudy fluid with little blood (synovial fluid analysis abnormal, synovial fluid red blood cells, latency: 8 days).Consumer wanted to report the issue.Hcp discontinued the product.She would not get third injection.She was still in pain and had imaging done.It was recommended that she follow-up with ortho.The report showed knee joint space narrowing (joint space narrowing, latency: unknown), and bone density loss (bone density decreased, latency: unknown).Action taken: drug withdrawn for all the events.Corrective treatment: fluid drained for injection site joint effusion, not reported for rest of events.Outcome: not recovered for the event left knee pain, unknown for rest all the events.A product technical compliant (ptc) was initiated on (b)(6) 2022 for synvisc (lot - unknown) with global ptc number (b)(4) and results were pending for the same.The sample status of the ptc (product technical complaint) was requested and awaited.Additional information was received on 24-mar-2022 from other healthcare professional.Gptc number and strength was added.Clinical course of event was added.Upon internal review, event added- drainage was a cloudy fluid with little blood.Lab data added.Additional information was received on 03-may-2022 from a patient.Synvisc injection dates added.Batch number was added.Events added- bone density loss and knee joint space narrowing.Outcome of left knee pain was updated.Clinical course was updated.Text was amended accordingly.

• 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: 13983085
• MDR Text Key: 288603177
• Report Number: 2246315-2022-00031
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: ARSP013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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
• Patient Sex: Female