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

Lot Number BRSL011

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

Patient Problems Loss of Range of Motion (2032); Arthralgia (2355); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2021

Event Type  Injury  

Event Description

Unable to bend his knee [joint range of motion decreased] unable to walk [unable to walk] removed liquid from the knee [arthrocentesis] unable to bend his knee and was painful/ still in pain and is worse now before getting the injection [arthralgia aggravated] knee became very swollen [swelling of l knee] case narrative: initial information received on 26-oct-2021 from united states regarding an unsolicited valid serious case received from the non-healthcare professional. This case involves a (b)(6) male patient who was unable to bend his knee, unable to walk, his doctor removed liquid from the knee, unable to bend his knee and was painful/ still in pain and is worse now before getting the injection and his knee became very swollen with the use of medical device 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. On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, (formulation, batch number, route: unknown) for osteoarthritis in left knee. On (b)(6) 2021, after the latency of 1 day of starting the treatment with hylan g-f 20, sodium hyaluronate, patient was unable to walk (gait disturbance), his knee became very swollen (joint swelling), therefore unable to bend his knee and was painful (joint range of motion decreased) (arthralgia). On (b)(6) 2021, after the latency of 2 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient's doctor removed liquid from the knee (aspiration joint) (intervention required) from his knee. On (b)(6) 2021, it happened again and on the (b)(6) 2021 the more liquid was removed. The patient was still in pain and was worse now than before getting the injection. The patient had to walk with a cane and had missed work because of his knee action taken: not applicable for all the events. Corrective treatment: cane for unable to walk, removal of liquid from joint swelling, joint range of motion decreased, arthralgia; not reported for rest all the events. Outcome: unknown for unable to bend his knee, removed liquid from the knee; not recovered for rest all the events. Seriousness criteria: disability for unable to walk, intervention required for rest all the events.

• 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: 12726557
• MDR Text Key: 284815280
• Report Number: 2246315-2021-00169
• 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,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: BRSL011
• 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 Treatment Data

Date Received: 11/01/2021 Patient Sequence Number: 1