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

Lot Number 8RSL029

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

Patient Problems Arthritis (1723); Bacterial Infection (1735); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 23-jan-2021: this case concerns a patient who was on treatment with synvisc one in left knee and had severe staph infection which required hospitalization and 2 clean out surgeries. The plausible causal role of the device cannot be denied, however, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.

Event Description

Severe staph infection (left knee) [arthritis bacterial] ([staphylococcal infection]). Loss of cartilage and ultimately a loss of function and stability (left knee) [musculoskeletal disorder]. Loss of cartilage and ultimately a loss of function and stability (left knee) [cartilage disorder]. Loss of cartilage and ultimately a loss of function and stability (left knee) [joint instability]. Case narrative: initial information received from united states on 15-jan-2021 from patient (significant) and healthcare professional (non-significant) regarding an unsolicited valid serious case. This case involves adult patient who experienced severe staph infection (left knee), loss of cartilage and ultimately a loss of function and stability (left knee), while he/she was treated with 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. Patient had purchased a number of hylan g-f 20, sodium hyaluronate injections to use overtime. On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection in left knee (dose, frequency, route, indication, batch number: unknown). Information on the batch number was requested. On an unknown date in (b)(6) 2020 (last (b)(6)), patient had a severe staph infection (arthritis bacterial; staphylococcal infection) which resulted in hospitalization, 2 clean out surgeries, a loss of cartilage and ultimately a loss of function and stability (chondropathy, musculoskeletal disorder, joint instability). Patient had 5 unopened, still in the box hylan g-f 20, sodium hyaluronate products that patient was not comfortable using. Patient could not say for sure if the infection was from the product or from an error in the injection. Patient wanted to send the remaining 5 boxes back for a refund and to identify if there was an issue with the batch of the product. Event of arthritis bacterial and its symptom was assessed as serious due to hospitalization and required intervention and was medically significant. Action taken: not applicable for all events. Corrective treatment: clean out surgeries for arthritis bacterial, not reported for rest of the events. Outcome: unknown for all events. A product technical complaint was initiated on 15-jan-2021 for synvisc one for unknown batch number and global ptc number: (b)(4) and results were pending for the same.

• 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: 11224091
• MDR Text Key: 230946896
• Report Number: 2246315-2021-00033
• 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,Followup,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/01/2021
• Device Lot Number: 8RSL029
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• 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: 01/25/2021 Patient Sequence Number: 1