MAUDE Adverse Event Report: HYMOVIS; HIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN - INTRAARTICULAR HYALURONIC ACID

Catalog Number 89122-0496-63

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Sepsis (2067); Renal Impairment (4499)

Event Type  Injury  

Event Description

On (b)(6) 2020 an (b)(6)-year-old male patient was treated with hymovis (hyaluronate sodium hexadecylamine) gel for injection, via intra-articular route, at the dose of 1 injection to both the right and the left knee.The product batch number was: d05600 (expiry date: 16/01/2023).The patient experienced streptococcal sepsis and renal insufficiency due to a suspected product quality issue.At the time of the reporting the outcome was not resolved.Reaction as described by the primary source: following the injection, a reaction developed: sepsis due to streptococcal infection.The patient with kidney and heart problems was admitted to intensive care, having decompensation due to renal insufficiency.Medical analysis revealed the diagnosis of streptococcus.No concomitant medication was not reported.Medical history include: kidney disorder and heart disorder.Results of the product quality control of the involved batch: no anomaly was found.Based on the performed investigation, the reported adverse event is not related to a possible defect of the product quality.No further information is available.

Manufacturer Narrative

This follow up has been opened to delete the catalog number.

Event Description

On (b)(6) 2020, an 89-year-old male patient was treated with hymovis (hyaluronate sodium hexadecylamide) gel for injection, via intra-articular route, at the dose of 1 injection to both the right and the left knee.The product batch number was: d05600 (expiry date: 16/01/2023).The patient experienced streptococcal sepsis and renal insufficiency due to a suspected product quality issue.At the time of the reporting the outcome was not resolved.Reaction as described by the primary source: following the injection, a reaction developed: sepsis due to streptococcal infection.The patient with kidney and heart problems was admitted to intensive care, having decompensation due to renal insufficiency.Medical analysis revealed the diagnosis of streptococcus.No concomitant medication was not reported.Medical history include: kidney disorder and heart disorder.Results of the product quality control of the involved batch: no anomaly was found.Based on the performed investigation, the reported adverse event is not related to a possible defect of the product quality.No further information is available.

• Brand Name: HYMOVIS
• Type of Device: HIGH MOLECULAR WEIGHT VISCOELASTIC HYALURONAN - INTRAARTICULAR HYALURONIC ACID
• MDR Report Key: 11384764
• MDR Text Key: 233742704
• Report Number: 9610200-2021-00002
• 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
• Report Date: 03/19/2021

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: No Information
• Device Catalogue Number: 89122-0496-63
• Device Lot Number: D05600
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 89 YR