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

Model Number 02.09.4001R

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 08/09/2021

Event Type  Injury  

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 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
• Type of Device: CEMENTED FIXED 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: 12438304
• MDR Text Key: 270400463
• Report Number: 3005180920-2021-00709
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825521
• UDI-Public: 07630030825521
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2016
• 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: 53 YR