MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 3 R; CEMENTED TIBIAL TRAY

Model Number	02.09.4003R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 4 months and a half after gmk-hinge system implantation because for the surgeon the tibial tray was badly positioned.The reason of hinge system implantation is unknown.
Additional Manufacturer Narrative
Batch review performed on 17 march 2022: lot 2004107: 10 items manufactured and released on 24-july-2020.Expiration date: 2025-07-17.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 3 R
• Common Device Name: CEMENTED TIBIAL TRAY
• 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: 14010351
• Report Number: 3005180920-2022-00226
• Device Sequence Number: 17236376
• Product Code: KRO
• UDI-Device Identifier: 07630030825569
• UDI-Public: 07630030825569
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/05/2022

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: 07/17/2025
• Device Model Number: 02.09.4003R
• Device Catalogue Number: 02.09.4003R
• Device Lot Number: 2004107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2020
• 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 Age: 89 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White