MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S6 LM

Model Number 02.18.TF6.LM

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 april 2020: lot 182129: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-06-19.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: less than 1 year after uka, the tibial component gets loose and the joint requires revision, probably to tka.Only one radiographic image is supplied, from which the tibial component looks in suboptimal position - we have no history, hence we do not know if this position was chosen at the time of index surgery or if it is the result of migration.The lateral view and the postoperative images could have helped to better understand.We have no reason to suspect a faulty device.

Event Description

The patient came in reporting pain due to a loose tibial tray and the cause is unknown.The surgeon removed the femoral component, tibial tray, and insert 10 months and a half after primary.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S6 LM
• 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: 9961388
• MDR Text Key: 192065631
• Report Number: 3005180920-2020-00246
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896798
• UDI-Public: 07630030896798
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: 02.18.TF6.LM
• Device Catalogue Number: 02.18.TF6.LM
• Device Lot Number: 182129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/18/2018
• 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