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

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

Patient Problems Pain (1994); Thyroid Problems (2102); Arthralgia (2355); No Code Available (3191)

Event Date 01/01/2003

Event Type  Injury  

Event Description

Hold for gary 2.9.Violent serious systemic pain reaction to the first synvisc injection [pain] ([subtherapeutic response]).Synvisc injection may have caused a thyroid auto immune response resulting in destruction of existing cartilage [autoimmune thyroid disorder].Hand specialist indicated that there is no cartilage in hands and elbows/destruction of cartilage throughout the body/destruction of existing cartilage [cartilage disorder].Hand, foot, shoulder and elbow pain become crippling/pain is devastating both physically and mentally [pain in extremity].Hand, foot, shoulder and elbow pain become crippling/pain is devastating both physically and mentally [joint pain].Case narrative: initial information from united states received on 14-dec-2020 regarding an unsolicited valid serious case from health authorities of united states under reference mw5097799 via patient.This case involves an unknown age female patient who experienced violent serious systemic pain reaction to the first synvisc injection, synvisc injection may have caused a thyroid auto immune response resulting in destruction of existing cartilage, hand specialist indicated that there is no cartilage in hands and elbows/destruction of cartilage throughout the body/destruction of existing cartilage, hand, foot, shoulder and elbow pain become crippling/pain is devastating both physically and mentally, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included largely tendinitis due to activity and abuse.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing hereditary predisposition to thyroid disease, osteoporosis and osteoarthritis (in 1999, uncontrollable through medication; however, bone density increased with fosamax, exercise and therapy), hashimotos ( that resulted in removal of thyroid gland).Patient had been closely monitored for osteoporosis, arthritis, bone density, x- rays and full body bone scans.On an unknown date in 2003, the patient received treatment with hylan g-f 20, sodium hyaluronate injections (series of 3 injections) via intra-articular route (dose, frequency and batch number unknown) for knee popped up resulting in excessive fluid buildup.At the time of injection, patient mentioned that her joint/cartilage was intact.On an unknown date in 2003, after receiving first hylan g-f 20, sodium hyaluronate injection, patient experienced violent serious systemic pain reaction (pain).However, patient had no problem with subsequent hylan g-f 20, sodium hyaluronate injections but she observed that medication did not offer substantive relief (therapeutic response decreased).On an unknown date in 2004, after latency of approximately 1 year, patient had hand, foot, shoulder and elbow pain which became crippling (pain in extremity and arthralgia), after which x-rays and hand specialist indicated that there was no cartilage in hands and elbows/destruction of cartilage throughout the body (chondropathy).Patient believed that hylan g-f 20, sodium hyaluronate injection might have caused a thyroid auto immune response (autoimmune thyroid disorder, event assessed as medically significant) resulting in destruction of existing cartilage.Recommended solution was tendon grafting to create cartilage in affected joint since she made up life by sculpting stone/bronze and painting and that pain was devastating both physically and mentally.Patient believed that rare combination of lack of thyroid gland, thyroid autoimmune reaction and the suspect might have triggered an anomalous response to hylan g-f 20, sodium hyaluronate resulting in disability and the need for surgical repair.These events were leading to disability and required intervention.Action taken: no action taken for pain; not applicable for rest all events.Corrective treatment: recommended solution of tendon grafting for chondropathy; not reported for rest events.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 23-dec-2020.Additional information was received on 23-dec-2020 from healthcare professional.Investigational results were 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: 11094192
• MDR Text Key: 233287146
• Report Number: 2246315-2020-00190
• 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: health professional
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: 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): Other; Required Intervention; Disability