MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM

Model Number 02.18.TF5.LM

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

Patient Problem Pain (1994)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 may 2021: lot 1902961: (b)(4) items manufactured and released on 27-aug-2019.Expiration date: 2024-07-28.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

The patient came in reporting pain due to a loose tibial component.The cause of the loose tibial component is unknown.The surgeon revised the tibial tray and insert 6 months after primary.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
• Type of Device: KNEE TIBIAL TRAY FIX 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: 11973855
• MDR Text Key: 255363421
• Report Number: 3005180920-2021-00479
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896774
• UDI-Public: 07630030896774
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2021

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
• Device Operator: Health Professional
• Device Model Number: 02.18.TF5.LM
• Device Catalogue Number: 02.18.TF5.LM
• Device Lot Number: 1902961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2019
• 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