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

Model Number 02.09.4003R

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288582797
• Report Number: 3005180920-2022-00226
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825569
• UDI-Public: 07630030825569
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.4003R
• Device Catalogue Number: 02.09.4003R
• Device Lot Number: 2004107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2020
• 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 Age: 89 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White