MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM

Model Number 02.18.TF2.RM

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 april 2021: lot 170790: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs director: few months after primary uka the medial tibial bone gives way completely and revision is required.We do not know if the bone failure was due to the consequences of the surgical preparation or to low mechanical quality of the bone.No trauma is reported.There is no reason to think that the failure is due to a defective implant.Corrected data: on the 29 april 2021 this mdr was sent to the fda test webtrader (https://esgtest.Fda.Gov) for error.Today 9 september 2021 we recognized the error and sent the mdr to fda production webtrader (https://esg.Fda.Gov).

Event Description

3 months after the primary surgery a revision was performed due to the sinking of the medial tibial plateau.The patient reported that she had not fallen.The surgeon revised all implants.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM
• Type of Device: KNEE 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: 12438439
• MDR Text Key: 270313162
• Report Number: 3005180920-2021-00341
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896729
• UDI-Public: 07630030896729
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162084
• 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: 06/07/2022
• Device Model Number: 02.18.TF2.RM
• Device Catalogue Number: 02.18.TF2.RM
• Device Lot Number: 170790
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR