MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM

Model Number	02.09.0517H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 years and 11 months after primary, the patient came in reporting pain and the cause is unknown.No issue with the implants was detected.The surgeon revised all gmk-hinge components to competitor components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16-may-2025: lot 182058: (b)(4) items manufactured and released on 10-dec-2018.Expiration date: 26-nov-2023.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.Additional devices involved batch review performed on 16-may-2025: gmk-hinge 02.09.4005r fixed tibial tray size 5 r (k130299) lot 120937a: (b)(4) items manufactured and released on 29-nov-2017.Expiration date: 13-nov-2022.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.Lot father 120937: (b)(4) items manufactured and released on 02-jul-2012.Expiration date: 31-may-2017.No anomalies found related to the problem.Gmk-hinge 02.09.2605r femoral component size 5 r (k130299) lot 175671: (b)(4) items manufactured and released on 18-dec-2017.Expiration date: 23-nov-2022.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/17MM
• 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: 22121866
• Report Number: 3005180920-2025-00508
• Device Sequence Number: 12556657
• Product Code: KRO
• UDI-Device Identifier: 07630030825286
• UDI-Public: 07630030825286
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: 02.09.0517H
• Device Lot Number: 182058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown