MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM; KNEE REVISION INSERT

Model Number	02.09.0520H
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 december 2022: lot 182059: (b)(4) items manufactured and released on 26-june-2018.Expiration date: 2023-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Addtional component involved: gmk-hinge 02.09.He20 gmk-hinge hinge post extension 20 mm -tinbn coated (k210010) lot.2011024: (b)(4) items manufactured and released on 05-feb-2021.Expiration date: 2026-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.Subsequently, the patient came in reporting pain due to the knee incision opening up during physical therapy.On (b)(6) 2022, the surgeon performed a washout and swapped the poly.On (b)(6) 2022, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and post extension.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM
• Common Device Name: KNEE REVISION 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16061012
• Report Number: 3005180920-2022-00980
• Device Sequence Number: 2033882
• Product Code: KRO
• UDI-Device Identifier: 07630030825293
• UDI-Public: 07630030825293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2022

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: 06/07/2023
• Device Model Number: 02.09.0520H
• Device Catalogue Number: 02.09.0520H
• Device Lot Number: 182059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2018
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White