MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 LM; TIBIAL TRAY FIXED CEMENTED

Model Number 02.18.TF4.LM

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

Patient Problem Failure of Implant (1924)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 april 2021: lot 1908024a: (b)(4) items manufactured and released on 10-jan-2020.Expiration date: 2024-11-17.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.

Event Description

Primary performed in (b)(6) 2020.In (b)(6) 2021, following tibial loosening, the surgeon successfully revised all components and resurfaced the natural patella.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S4 LM
• Type of Device: TIBIAL TRAY FIXED CEMENTED
• 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: 11782835
• MDR Text Key: 249233361
• Report Number: 3005180920-2021-00359
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896750
• UDI-Public: 07630030896750
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.TF4.LM
• Device Catalogue Number: 02.18.TF4.LM
• Device Lot Number: 1908024A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2020
• 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