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

Model Number 02.18.TF5.LM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 february 2021: lot 1900847: (b)(4) items manufactured and released on 05-july-2019.Expiration date: 2024-06-23.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 after 1 years and 2 months from the primary surgery 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.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM
• Type of Device: TIBIAL TRAY 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: 11331834
• MDR Text Key: 231998740
• Report Number: 3005180920-2021-00119
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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: 1900847
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2019
• 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