MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM; KNEE TIBIAL INSERT

Catalog Number 02.07.0410SCF

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 march 2024: lot 167674: (b)(4) items manufactured and released on 03-jan-2017.Expiration date: 2021-12-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.:.

Event Description

Revision due to an infection and the pathogen is unknown.At about 5 years and 4 months post primary the surgeon performed a washout and revised the liner.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19086068
• MDR Text Key: 339877026
• Report Number: 3005180920-2024-00223
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817656
• UDI-Public: 07630030817656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Expiration Date: 12/05/2021
• Device Catalogue Number: 02.07.0410SCF
• Device Lot Number: 167674
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2017
• 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
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Race: White