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

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

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 04/07/1999

Event Type  Injury  

Event Description

Acute synovitis (right knee) [injection site synovitis].Pain in the knee (right knee)/range of 0-120 degrees with pain at maximum flexion [injection site joint pain].Swelling of right knee [injection site joint swelling].Right knee developed effusion 20-30 cc/residual effusion 30 cc [injection site joint effusion].Case narrative: initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a pharmacist via health authorities of united states under reference mw5097751.This case involves an adult patient (with unknown gender) who experienced acute synovitis (right 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 07-apr-1999, the patient received one injection of hylan g-f 20, sodium hyaluronate in right knee (dose, frequency, indication, lot - unknown).Information on batch number was requested.On same evening of injection, the patient developed pain in the knee (injection site joint pain).The patient went in for follow up visit with ortho.Right knee developed effusion 20-30 cc (injection site joint effusion), there was no erythema, range of motion 0-135 degrees without significant pain.On follow up visit, pain and swelling of right knee (injection site joint swelling) was resolving, there was no erythema, range of 0-120 degrees with pain at maximum flexion.The patient had residual effusion 30 cc.The patient's diagnosis was acute synovitis (injection site joint inflammation; onset, latency: unknown).This event required intervention.Action taken: unknown it was not reported if the patient received a corrective treatment.Outcome: unknown.A product technical complaint (ptc) was initiated on 09-nov-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: 22-jan-2021 follow up information received on 11-jan-2021 from other healthcare professional.Global ptc number added.Additional information was received on 22-jan-2021 from healthcare professional.Investigational results were added.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: 11256871
• MDR Text Key: 229658542
• Report Number: 2246315-2021-00049
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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): Required Intervention