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

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

Patient Problems Inflammation (1932); Muscle Weakness (1967); Pain (1994); Arthralgia (2355); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Unspecified Gastrointestinal Problem (4491); Swelling/ Edema (4577)

Event Date 03/16/2021

Event Type  Injury  

Event Description

Could not bear weight on the leg [weight bearing difficulty].Could not walk [unable to walk].Synovitis with only signs of inflammation [synovitis] ([swelling of r knee], [arthralgia aggravated], [effusion (r) knee]).Drained about 120cc of synovial fluid/ had another 40cc of fluid drained off (right knee) [arthrocentesis].Could not bend the leg or fully straighten it/leg stiffness [limbs stiffness].Weakness in leg [muscle weakness lower limb].Stomach issues/unspecified stomach problems [gastrointestinal disorder].Trouble sleeping [difficulty sleeping].Case narrative: based on additional information received on 27-may-2021, the case initially non serious was upgraded toserious (serious event: synovitis added).Initial information from (b)(6) received on 25-mar-2021 regarding an unsolicited valid serious case received from a patient.This case involves adult female patient who could not bear weight on the leg, could not walk, developed synovitis with only signs of inflammation, drained about 120cc of synovial fluid/ had another 40cc of fluid drained off (right knee), could not bend the leg or fully straighten it/leg stiffness, weakness in leg, stomach issues/unspecified stomach problems and trouble sleeping 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.Patient had received synvisc one in her right knee a little over 6 months ago ((b)(6) 2020) with good results and no complications.At the time, she had little to no effusion and felt the effects of the treatment in about 3 weeks.In (b)(6) 2021 the patient had mild effusion of the joint, the physician drained about 30-40cc of synovial fluid from the knee before injecting synvisc one.On (b)(6) 2021, the patient received treatment with hylan g-f 20, sodium hyaluronate injection once (dose, route and batch number unknown) for unknown indication.The patient indicated there was no way to provide the lot number of the treatment as the package was thrown away after administering.Initially the patient had no problems and rested for two days and iced regularly.After that she resumed normal walking and standing activity but held off strenuous sports, but then, it started blowing up.On (b)(6) 2021, after around 5 days or so, patient's knee became very swollen (joint swelling) and painful.The patient informed that she had more pain after this injection than she did with her initial injury and was worse off than before (arthralgia).The physician then drained about 120cc of synovial fluid (aspiration joint) (which was clear and slightly yellow) and this helped relief some of the pain and pressure.At that point the patient indicated that it was so bad that she could not walk (gait inability) (medically significant) or bear weight on the leg (weight bearing difficulty) (medically significant).She had trouble sleeping (insomnia).The patient indicated that she could not bend the leg or fully straighten it/ leg stiffness (musculoskeletal stiffness).Another 3 days later the patient returned to her physician and had another 40cc of fluid drained off.The patient informed that she could not take many non-steroidal anti-inflammatory drugs as she has a bad reaction due to stomach issues/ unspecified stomach problems (gastrointestinal disorder) so had to rely on rest, ice (every 2 hours), massage, and topical medicine.At this point the knee slowly improved.The patient had an mri (magnetic resonance imaging) that showed severe synovitis (medically significant).Doctor did not think there was an infection present, but he did not send it for analysis of bacteria/ crystals, etc.Labs did not show any sign of infection only signs of inflammation.As of (b)(6) 2021, the patient still has stiffness, effusion (joint effusion), pain in the knee along with weakness in leg (muscular weakness).The patient would be returning to her physician on (b)(6) 2021 to follow up.Action taken: not applicable for all the events.Corrective treatment: rest, ice, massage, and topical medicine for synovitis; not reported for rest of the events.Outcome: not recovered for muscular weakness, musculoskeletal stiffness; unknown for gastrointestinal disorder, insomnia; not applicable for aspiration joint; recovering for rest of the events.A product technical complaint (ptc) was initiated on 13-apr-2021 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 21-apr-2021.Additional information was received on 21-apr-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Additional information was received on 27-may-2021 from patient.Case upgraded to serious.Events added: synovitis with only signs of inflammation, drained about 120cc of synovial fluid/ had another 40cc of fluid drained off (right knee), could not bend the leg or fully straighten it/leg stiffness, weakness in leg, stomach issues/unspecified stomach problems and trouble sleeping.Laboratory data added.Onset dates updated for events could not bear weight on the leg, could not walk and these were updated to serious.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: 11931547
• MDR Text Key: 267042500
• Report Number: 2246315-2021-00110
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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