MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE3 L; KNEE REVISION FEMORAL COMPONENT

Model Number 02.09.2603L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Infection (1930)

Event Date 11/22/2021

Event Type  Injury  

Event Description

About 2 months after the previous revision surgery(previously all implants were revised due to the tibia tendon had come off), the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 29 november 2021.Lot 2010962: (b)(4) items manufactured and released on 26-feb-2021.Expiration date: 2026-feb-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Addtional components involved: gmk-hinge 02.09.0314h fixed tibial insert size 3/14mm (k130299) lot.178882 lot 178882: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-apr-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-hinge 02.09.4003l fixed tibial tray size 3 l (k130299) lot.172031 lot 172031: (b)(4) items manufactured and released on 28-jun-2017.Expiration date: 2022-jun-12.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE3 L
• Type of Device: KNEE REVISION FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13042794
• MDR Text Key: 282493839
• Report Number: 3005180920-2021-00991
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825439
• UDI-Public: 07630030825439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• 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: 12/20/2021

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: Health Professional
• Device Model Number: 02.09.2603L
• Device Catalogue Number: 02.09.2603L
• Device Lot Number: 2010962
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2021
• 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 Sex: Female