MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM

Catalog Number 02.18.TF3.RM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 01 october 2018; lot 167756: (b)(4) items manufactured and released on 15 february 2017.Expiration date: 2022-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on october 04, 2018 early loosening of a unicompartmental knee replacement occurred 2 months after primary surgery.Radiographic image provided doesn't allow a proper clinical investigation: no immediate post primary image is available.On the basis of information received, no conclusion can be drawn.

Event Description

Revision due to loosening of the tibial tray 2 months after the primary, due to a weakening of the underlying bone stock.The surgeon revised all the devices.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 RM
• Type of Device: TIBIAL TRAY FIX CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7933739
• MDR Text Key: 122645785
• Report Number: 3005180920-2018-00743
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896743
• UDI-Public: 07630030896743
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Catalogue Number: 02.18.TF3.RM
• Device Lot Number: 167756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2022
• 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: 66 YR
• Patient Weight: 95