MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R; CEMENTED FIXED TIBIAL TRAY

Model Number	02.09.4001R
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review was performed on 06 september 2021: lot 164808: (b)(4) items manufactured and released on 7-sep-2016.Expiration date: 2021-08-28.No anomalies found related to the problem.To date, (b)(4) tems of the same lot have been sold without any similar reported event since 2017.Additonal implant involved: gmk-hinge 02.07.0003 offset connector 3 mm (k102437) lot.(b)(4) batch review was performed on 06 september 2021: lot 187637: (b)(4) items manufactured and released on 7-nov-2018.Expiration date: 2023-10-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additonal implant involved: gmk-hinge 02.07.Fcl14065 extension stem - fluted ¿ 14 l 65 (k120790) lot.165108 batch review was performed on 06 september 2021: lot 165108: (b)(4) items manufactured and released on 16-nov-2016.Expiration date: 2021-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Additonal implant involved: gmk-hinge 02.09.0114h fixed tibial insert size 1/14mm (k130299) lot.162427 batch review was performed on 06 september 2021: lot 162427: (b)(4) items manufactured and released on 9-may-2016.Expiration date: 2021-04-19.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director 2.5 years after tka (presumably revision), the patient feels discomfort and the surgeon decides to re-position the tibial component to give more varus.The surgeon confirmed the prosthesis was not found loose.No reason to suspect a faulty device at the origin of this reoperation.
Event or Problem Description
2 years and 7 months after the primary surgery the patient had pain and suspected a loose prosthesis.The prosthesis was not loose but the surgeon decided to explant the tibia and build more varus with the new one.

• Brand Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 1 R
• Common Device Name: CEMENTED FIXED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12438304
• Report Number: 3005180920-2021-00709
• Device Sequence Number: 3779467
• Product Code: KRO
• UDI-Device Identifier: 07630030825521
• UDI-Public: 07630030825521
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 09/08/2021

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: 08/28/2021
• Device Model Number: 02.09.4001R
• Device Catalogue Number: 02.09.4001R
• Device Lot Number: 164808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR