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

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

Patient Problem Arthritis (1723)

Event Date 05/26/1999

Event Type  Injury  

Event Description

Had a reaction to the synvisc without infection/can't rule out the possibility of a crystalline arthritis (e.G., pseudogout) triggered by the injections (left knee) [crystal arthritis (excl gout)] ([c-reactive protein increased], [injection site joint pain], [injection site joint swelling], [injection site joint warmth]).Case narrative: this case is linked to case (b)(4) (2nd injection, multiple devices) and (b)(4) (3rd injection, multiple devices).Initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097844.This case involves an unknown age female patient who had a reaction to the synvisc without infection/can't rule out the possibility of a crystalline arthritis (e.G., pseudogout) triggered by the injections (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) in left knee.The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.At the time of the event, the patient had ongoing osteoarthritis of the knees and poorly tolerant to nsaids.The patient had x-ray and clinical exam and agreed for a series of synvisc injections for the left knee.On an unknown date in 1999, the patient received first injection of series of synvisc (hylan g-f 20, sodium hyaluronate) via intra-articular route in left knee for osteoarthritis of the knees (dose, frequency, and lot - unknown).There will be no information available on the batch number of this case.Reportedly, the injection seemed technically satisfactory, with the synvisc injected within the joint space.On (b)(6), unknown latency following the synvisc injection, the patient developed severe left knee pain (injection site joint pain).She was seen on an unknown date in 1999 and there appeared to be mild warmth (injection site joint warmth; latency: unknown) and swelling (injection site joint swelling; latency: unknown).C-reactive protein was 2.9 (normal less than 1.4) (c-reactive protein increased; latency: unknown).The patient had no fever.A diagnostic left knee aspiration was performed, no fluid was obtained (dry tap).She was treated with choline magnesium (mg) salicylate.She was re-examined on an unknown date in 1999, and the knee was significantly better (back towards baseline), without effusion.It was believed that the patient had a reaction to the synvisc without infection (she received no antibiotics), although possibility of a crystalline arthritis (e.G., pseudogout) could not be ruled out which was triggered by the injections (crystal arthropathy).All events were assessed as medically significant.Final diagnosis was severe left knee pain, appeared to be mild warmth and swelling (left knee), c-reactive protein was 2.9 and had a reaction to the synvisc without infection/can't rule out the possibility of a crystalline arthritis (e.G., pseudogout) triggered by the injections (left knee).Action taken: no action taken.Corrective treatment: choline magnesium salicylate.The patient outcome is reported as recovering/ resolving.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 as received on 23-dec-2020 from other healthcare professional.Investigation results added.Narrative 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: 11073612
• MDR Text Key: 231130820
• Report Number: 2246315-2020-00179
• 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: 12/25/2020

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/25/2020
• 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