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

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

Patient Problems Pain (1994); Swelling (2091); Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Event Description

Developed a blood clot after the surgery in left leg [postoperative thrombosis].Her right leg is worse than her left leg/she is getting worse and worse [lower extremity dysfunction] ([condition worsened].) could not sit down and her husband had to help her to the bathroom [movements reduced].Cant sleep because of the pain [difficulty sleeping].Swelling [swelling nos].Stiffness [stiffness].Bad pain/horrible pain [pain nos].On her right leg she cant hardly walk on its horrible [unable to walk].Had surgery on her left leg [leg operation].Off label use [off label use of device].Case narrative: upon internal review on (b)(6) 2020, the case initially assessed as non-serious was upgraded to serious (medically significant for developed a blood clot after the surgery in left leg).This case is linked to case (b)(4) (multiple device for same patient) initial information received on 19-aug-2020 regarding an unsolicited valid serious case received from a patient via call center.This case involves an unknown age female patient who developed a blood clot after the surgery in left leg, her right leg is worse than her left leg/she is getting worse and worse, could not sit down and her husband had to help her to the bathroom, can't sleep because of the pain, on her right leg she can't hardly walk on its horrible, swelling, stiffness, bad pain/horrible pain, had surgery on her left leg and off label use, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate solution for injection in left knee once (dose, route and batch number unknown) for unknown indication.On an unknown date in 2017, couple of days after receiving the hylan g-f 20, sodium hyaluronate, she went to her primary care doctor because she was experiencing horrible pain (pain).On an unknown date, after unknown latency, patient reported swelling, stiffness (musculoskeletal stiffness) and bad pain.The patient could not sleep because of the pain (insomnia) (onset date and latency: unknown).The patient could not sit down, and her husband had to help her to the bathroom (hypokinesia).Patient further reported that her right leg was worse than her left leg (musculoskeletal disorder) (condition aggravated).It was reported that was feeling better but now she was getting worse and worse.On the right leg she could not hardly walk on and it was horrible (gait inability).An ultrasound was done on both legs to check for blood clots, but no blood count was found.On an unknown date, after unknown latency, patient also had surgery on her left leg (limb operation) after receiving the hylan g-f 20, sodium hyaluronate injection and developed a blood clot after the surgery (postoperative thrombosis; event was assessed as medically significant) and patient recovered from clot on an unknown date.On an unknown date, after unknown latency, off label use (off label use of device) was reported.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.The patient outcome is reported as recovered/resolved for developed a blood clot after the surgery in left leg; not applicable for off label use; unknown for rest all the events.A product technical complaint (ptc) was initiated on 19-aug-2020 for synvisc one 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 are 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 corrective and preventive action (capa) was required.Investigation completion date: 24-aug-2020 additional information was received from healthcare professional on 19-aug-2020 (non-significant) and 24-aug-2020 (significant) processed with clock start date of 24-aug-2020.Global ptc number and its results were added.Upon internal review, the event of developed a blood clot after the surgery in left leg was updated to medically significant and case upgraded to serious.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 10466207
• MDR Text Key: 213240922
• Report Number: 2246315-2020-00104
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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