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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

She had two syringes drained out of her knee [knee effusion].She couldn't walk on it [walking difficulty].She has fevers on and off [fever].Her knees got really hot [injection site joint warmth].Blew up the size of cantaloupes, her left knee, was much worse meaning it was bigger in size/ big giant knees again [injection site joint swelling].That were "burning" [injection site burning].Case narrative: initial information from united states received on 30-jun-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional).This case involves a (b)(6) female patient who couldn't walk on it, she has fevers on and off, her knees got really hot, blew up the size of cantaloupes, her left knee, was much worse meaning it was bigger in size/ big giant knees again, that were "burning" and she had two syringes drained out of her knee while being treated with 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 an unknown date, the patient received 16mg/2ml synvisc injection, liquid (solution) (3 injections) (lot, dose, frequency, indication: unknown) in right knee.In context of covid-19 crisis, information on batch number was requested.On an unknown date, after the first and second injections she didn't feel anything but by the third injection her knees got really hot (injection site joint warmth; latency unknown) and several days later they blew up the size of cantaloupes (injection site joint swelling).Reportedly, her one knee, her left knee, was much worse meaning it was bigger in size and she couldn't walk on it (gait disturbance) or put any pressure on it.The patient had two syringes drained out of her knee (joint effusion; intervention required) on monday and now they have blown up again.The patient had relief within hours of the draining but the next morning she had big giant knees again that were burning (injection site joint pain).The patient was using ice and on heavy doses of ibuprofen but 24 hours after draining it her knee was back to the size of her thigh and there was no difference in size from her upper thigh to her knee and it was burning hot and she has fevers on and off (pyrexia; latency unknown).It was reported that she couldn't keep going through having this and she was prescribed keflex the other day, her doctor was "getting stuff analyzed" but she was not good with downtime.Action taken: not applicable for all events.The patient was treated with ibuprofen sodium (ibuprofen [ibuprofen sodium]) and cefalexin (keflex [cefalexin]) for all events.At time of reporting, the outcome was not recovered / not resolved for all events.Product technical complaint (ptc) was initiated with (b)(4) on 30-jun-2021 for product.Batch number; unknown.Device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.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-conformance 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 safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: 27-jul-2021.Additional information was received on 30-jun-2021 from healthcare professional.Global ptc number added, strength added and formulation updated for suspect.Narrative amended accordingly.Additional information was received on 27-jul-2021 from healthcare professional.Global ptc results and number added.Text was amended accordingly.Additional information was received on 14-sep-2021 from the patient.Case upgraded to serious upon internal review.Lab added.Clinical course was updated.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12516417
• MDR Text Key: 280835673
• Report Number: 2246315-2021-00152
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention