MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FEMORAL COMPONENT SIZE 4 L

Model Number	02.09.2604L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-oct-2024.(b)(4) items manufactured and released on 02-may-2017.Expiration date: 2022-04-03.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.Additional implants involved: gmk-hinge 02.07.0035rp patella resurfacing size 3 (k090988) lot.2237722 (b)(4) items manufactured and released on 10-nov-2022.Expiration date: 2027-10-25.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.Gmk-hinge 02.09.0414h fixed tibial insert size 4/14mm(k130299) lot.2114873 (b)(4) items manufactured and released on 15-feb-2022.Expiration date: 2027-01-19.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.Gmk-hinge 02.09.4004l fixed tibial tray size 4 l (k130299) lot.171443 (b)(4) items manufactured and released on 26-apr-2017.Expiration date:2022-04-10.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.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.On (b)(6) 2023, the patient came in reporting pain and the cause was unknown.The surgeon resurfaced the patient's natural patella and revised the poly.The surgery was completed successfully.On (b)(6) 2024, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all gmk-hinge components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FEMORAL COMPONENT SIZE 4 L
• 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: 20693481
• Report Number: 3005180920-2024-00945
• Device Sequence Number: 20693229
• Product Code: KRO
• UDI-Device Identifier: 07630030825453
• UDI-Public: 07630030825453
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: 02.09.2604L
• Device Lot Number: 168958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male