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

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

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 10/30/1998

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 17-dec-2020: this case involves a patient who experienced acute onset of pain and swelling of left knee and tense effusion, warmth and pain with range of motion, eighty milliliters of yellowish synovial fluid was withdrawn (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product could not be denied.Further, detailed information regarding batch number, investigation results, patient¿s allergic history, underlying condition of knee, concurrent clinical presentation, concomitant medications, past medications, relevant medical history and other risk factors would aid in better case assessment.

Event Description

Acute onset of pain and swelling of left knee/pain with range of motion (left knee) [injection site joint pain] ([pain upon movement]).Acute onset of pain and swelling of left knee [injection site joint swelling].Warmth (left knee) [injection site joint warmth].Tense effusion/ eighty milliliters of yellowish synovial fluid was withdrawn (left knee) [injection site joint effusion].Case narrative: initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from a pharmacist via health authorities of united states under reference mw5097841.This case involves patient (with unknown demographics) who experienced acute onset of pain and swelling of left knee/pain with range of motion (left knee), warmth and tense effusion/ eighty milliliters of yellowish synovial fluid was withdrawn (left knee), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On (b)(6) 1998, the patient received 3rd injection of synvisc (hylan g-f 20, sodium hyaluronate) via intra-articular route in left knee by orthopaedic surgeon (dose, frequency, indication and lot - unknown).There would be no information available on the batch number of this case.On (b)(6) 1998, the following morning (a.M.) after the injection, the patient experienced acute onset of pain (injection site joint pain) and swelling of left knee (injection site joint swelling).On physical exam, the patient had tense effusion (injection site joint effusion), warmth (injection site joint warmth) and pain with range of motion (pain).It was reported that eighty milliliters of yellowish synovial fluid was withdrawn and sent for studies.Patient managed with non-steroidals and standard mobilization techniques.All events were assessed as medically significant.Final diagnosis was tense effusion/ eighty milliliters of yellowish synovial fluid was withdrawn (left knee), warmth and acute onset of pain and swelling of left knee/pain with range of motion (left knee).Action taken: not applicable for all the events.Corrective treatment: non-steroidals and standard mobilization techniques for all the events; also, synovial fluid was withdrawn for injection site joint effusion.The patient outcome is reported as unknown for all the events.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr 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 as to determine if a capa was required.Final investigation was completed on 23-dec-2020.Follow up information was received on 14-dec-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 23-dec-2020 from a healthcare professional.Ptc results received and processed.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: 11100141
• MDR Text Key: 231578977
• Report Number: 2246315-2020-00195
• 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: 12/31/2020

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: 12/31/2020
• Was Device Evaluated by Manufacturer?: No
• 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