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

Lot Number UNKNOWN

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

Patient Problem Peripheral Edema (4578)

Event Date 06/22/2021

Event Type  Injury  

Event Description

Drain the knee [arthrocentesis].Had their first injection and their knee became edematous [oedema knees].Drained fluid was greenish/ yellow in color [synovial fluid colour].Results demonstrated one part calcium and 1 part of pyrophosphate crystals [synovial fluid crystal present].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a physician from united states.This case involves a (b)(6) male patient who had their first injection and their knee became edematous, experienced drain the knee, drained fluid was greenish/ yellow in color and results demonstrated one part calcium and 1 part of pyrophosphate crystals 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate (formulation, batch number, dosage, indication, route: unknown).On the same day, the patient had their first injection and their knee became edematous (oedema peripheral) and the doctor proceeded to drain the knee (arthrocentesis) (medically significant); the drained fluid was greenish/yellow in color and sent to the lab for analysis (synovial fluid analysis ); the results demonstrated one part calcium and 1 part pyrophosphate crystals (synovial fluid crystal present).On (b)(6) 2021, patient had his second injection.Action taken: no action taken for all the events.It was not reported if the patient received a corrective treatment for the events (had their first injection and their knee became edematous, drain the knee, drained fluid was greenish/ yellow in color, results demonstrated one part calcium and 1 part of pyrophosphate crystals).Outcome: unknown for all the events.

Event Description

Drain the knee [arthrocentesis].Had their first injection and their knee became edematous [oedema knees].Drained fluid was greenish/ yellow in color [synovial fluid colour].Results demonstrated one part calcium and 1 part of pyrophosphate crystals [synovial fluid crystal present].Similar reaction -pain knee [knee pain].Case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a physician from united states.This case involves a 60 years old male patient who had their first injection and their knee became edematous, experienced drain the knee, drained fluid was greenish/ yellow in color and results demonstrated one part calcium and 1 part of pyrophosphate crystals, similar reaction -pain 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate (formulation, batch number, dosage, indication, route: unknown).On the same day, the patient had their first injection and their knee became edematous (oedema peripheral) and the doctor proceeded to drain the knee (arthrocentesis) (medically significant); the drained fluid was greenish/yellow in color and sent to the lab for analysis (synovial fluid analysis ); the results demonstrated one part calcium and 1 part pyrophosphate crystals (synovial fluid crystal present).Reportedly, on an unknown date in (b)(6) 2021, after the patient had synvisc injected into the knee on occas was within 1 month with similar reaction -pain (arthralgia; latency: approximately 1 month) efficacy reported to aspiraton injection aspirate with cppd (calcium pyrophosphate dehydrate) crystal injection reaction to other product.On (b)(6) 2021, patient had his second injection.Action taken: no action taken for all the events.It was not reported if the patient received a corrective treatment for the events (had their first injection and their knee became edematous, drain the knee, drained fluid was greenish/ yellow in color, results demonstrated one part calcium and 1 part of pyrophosphate crystals, similar reaction -pain ).Outcome: unknown for all the events.Additional information was received on 14-sep-2021 from the non-healthcare professional.Event added for similar reaction -pain.Clinical course was updated.Text amended accordingly.

Event Description

Drain the knee [arthrocentesis] had their first injection and their knee became edematous [oedema knees] drained fluid was greenish/ yellow in color [synovial fluid colour] results demonstrated one part calcium and 1 part of pyrophosphate crystals [synovial fluid crystal present] similar reaction -pain knee [knee pain] no relief from arthritic symptoms with either synvise injections [device ineffective] case narrative: initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a physician from united states.This case involves a 60 years old male patient who had their first injection and their knee became edematous, experienced drain the knee, drained fluid was greenish/ yellow in color and results demonstrated one part calcium and 1 part of pyrophosphate crystals, similar reaction -pain knee and no relief from arthritic symptoms with either synvise injections, 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.Concomitant medications included methylprednisolone acetate (depomedrol) and hyaluronate sodium (gelsyn 3).On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate (formulation, batch number, dosage, indication, route: unknown).On the same day, the patient had their first injection and their knee became edematous (oedema peripheral) and the doctor proceeded to drain the knee (arthrocentesis) (medically significant); the drained fluid was greenish/yellow in color and sent to the lab for analysis (synovial fluid analysis ); the results demonstrated one part calcium and 1 part pyrophosphate crystals (synovial fluid crystal present).Reportedly, on an unknown date in (b)(6) 2021, after the patient had synvisc injected into the knee on occas was within 1 month with similar reaction -pain (arthralgia; latency: approximately 1 month) efficacy reported to aspiration injection aspirate with cppd (calcium pyrophosphate dehydrate) crystal injection reaction to other product.On (b)(6) 2021, patient had his second injection.Upon follow-up, it was reported that since an unknown date and latency, patient treated with depomedrol with resolution but no relief from arthritic symptoms with either synvisc injections (device ineffective), patient subsequently used gelsyn without reaction.Action taken: not applicable for device ineffective, no action taken for all the events.It was not reported if the patient received a corrective treatment for the events (had their first injection and their knee became edematous, drain the knee, drained fluid was greenish/ yellow in color, results demonstrated one part calcium and 1 part of pyrophosphate crystals, similar reaction -pain, device ineffective ).Outcome: unknown for all the events.A product technical complaint (ptc) was initiated with global ptc number: (b)(4) on 28-jan-2022 for product.Batch number: unknown.Sample status: not available.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.Final investigation complete date was 04-feb-2022.Sanofi would continue to monitor complaints as stated in sop (b)(4), "product event handling" to determine if a capa was required.Additional information was received on 14-sep-2021 from the non-healthcare professional.Event added for similar reaction -pain.Clinical course was updated.Text amended accordingly.Additional information was received on 27-jan-2022 from the non-healthcare professional.Additional event of device ineffective was added.Text amended accordingly.Additional information was received on 04-feb-2022 from the quality department.Ptc results added.Text 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: 12242500
• MDR Text Key: 279882930
• Report Number: 2246315-2021-00130
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Treatment: DEPOMEDROL (METHYLPREDNISOLONE ACETATE),UNKNOWN.; GELSYN 3 (HYALURONATE SODIUM),UNKNOWN.
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male