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 Cancer (3262)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 15-mar-2024: this case involves an unknown age male patient who was diagnosed with cancer with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.However, further information of past and concomitant medication, any family history and any relevant medical history of patient, any concurrent would aid in better case assessment.

Event Description

Cancer [cancer].Shoulder osteoarthritis [shoulder osteoarthritis].Case narrative: initial information received from united states on 12-mar-2024 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age male patient who was diagnosed with cancer and had shoulder osteoarthritis after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc] and unspecified chemotherapy.The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection of strength: 16mg/2ml (with unknown dose, frequency, route, batch number and expiry date) for knee osteoarthritis.The patient mentioned being on synvisc years ago but was taken off it.Since 2011, after unknown latency, the patient had cancer (neoplasm malignant).Since an unknown date, he had developed shoulder osteoarthritis (osteoarthritis) (onset and latency: unknown) because of the chemo (chemotherapy) he was taking.Patient wanted to know why synvisc cannot be used on the shoulder.Patient wanted to know why his insurance was not approving synvisc if it was for the use of shoulder osteoarthritis.He also mentioned his doctor did not want to prescribe synvisc to him due to a lack of clinical trials.He expressed interest in participating in a clinical trial where synvisc was being tested for shoulder osteoarthritis.Action taken: unknown for both the events with synvisc.Action taken: unknown for osteoarthritis, not applicable for neoplasm malignant with unspecified chemotherapy.Corrective treatment: chemotherapy (unspecified) for neoplasm malignant; not reported for osteoarthritis.Outcome: not recovered / not resolved for both the events.Seriousness criteria: medically significant for neoplasm malignant.

Event Description

Cancer [cancer].Shoulder osteoarthritis [shoulder osteoarthritis].Case narrative: initial information received on 12-mar-2024 regarding an unsolicited valid serious case received from a patient.This case involves an unknown age male patient who was diagnosed with cancer and had shoulder osteoarthritis after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc] and unspecified chemotherapy.The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection of strength: 16mg/2ml (with unknown dose, frequency, route) for knee osteoarthritis.The patient mentioned being on synvisc years ago but was taken off it.Since 2011, after unknown latency, the patient had cancer (neoplasm malignant).Since an unknown date, he had developed shoulder osteoarthritis (osteoarthritis) (batch number, expiry date, onset and latency: unknown) because of the chemo (chemotherapy) he was taking.Patient wanted to know why synvisc cannot be used on the shoulder.Patient wanted to know why his insurance was not approving synvisc if it was for the use of shoulder osteoarthritis.He also mentioned his doctor did not want to prescribe synvisc to him due to a lack of clinical trials.He expressed interest in participating in a clinical trial where synvisc was being tested for shoulder osteoarthritis.Information regarding the batch number and expiry date was requested.Action taken: unknown for both the events with synvisc action taken: unknown for osteoarthritis, not applicable for neoplasm malignant with unspecified chemotherapy.Corrective treatment: chemotherapy (unspecified) for neoplasm malignant; not reported for osteoarthritis.Outcome: not recovered / not resolved for both the events.Seriousness criteria: medically significant, intervention required for neoplasm malignant.A product technical complaint (ptc) was initiated on 12-mar-2024 for synvisc (lot/batch and expiry date: unknown) with global ptc number: 100409175.The sample was not available and ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii - (dp 13mar24).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is 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 (non-conformance) process.Sanofi will continue to monitor complaints and trending as product event handling to determine if a capa is required.The final investigation was completed on 19-mar-2024 with summarized conclusion as no assessment possible.Additional information was received on 12-mar-2024 from the quality department.Ptc details added.Additional information was received on 19-mar-2024 from quality department: ptc details with summarized conclusion added.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: 18913852
• MDR Text Key: 337779237
• Report Number: 2246315-2024-00020
• 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
• Report Date: 03/21/2024

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2024
• 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): Other; Required Intervention
• Patient Sex: Male