MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.E0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS; KNEE TIBIAL INSERT FIXED

Catalog Number 02.12.E0410FR

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 03/14/2024

Event Type  Injury  

Event Description

The patient had a primary knee surgery on (b)(6) 2021.On (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.On (b)(6) 2024, the patient was revised for infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 21 march 2024.Lot 2310255: (b)(4) items manufactured and released on 01-jun-2023.Expiration date: 2028-05-17.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.Other devices involved: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 2009489: (b)(4) items manufactured and released on 16-dec-2020.Expiration date: 2025-12-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r (k121416) lot 2010168: (b)(4) items manufactured and released on 21-jan-2021.Expiration date: 2026-01-11.No anomalies found related to the problem.To date, all items of the same lot have been sold with other (b)(4) similar reported events during the period of review.

• Brand Name: GMK-SPHERE 02.12.E0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS
• Type of Device: KNEE TIBIAL INSERT FIXED
• 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: 19097070
• MDR Text Key: 340032748
• Report Number: 3005180920-2024-00213
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630971261761
• UDI-Public: 07630971261761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/12/2024

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 Catalogue Number: 02.12.E0410FR
• Device Lot Number: 2310255
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2023
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 156 KG
• Patient Race: White