MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK UNI FIXED TIBIAL INSERT; FIXED PE TIBIAL INSERT

Catalog Number 02.08.IF1.06.RMLL

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  Injury  

Manufacturer Narrative

The reason of this deformation was attributed to some high viscosity cement debris remained on the tibial tray surface at the clipping interface with the poly.Batch review performed on (b)(6) 2017.Lot 168938: 15 items manufactured and released on (b)(6) 2017.Expiration date: (b)(6) 2022.No anomalies found related to the problem.To date, 1 item of the same lot have been already sold.

Event Description

During the surgery the surgeon was not able to clip the inlay in the tibial tray.The surgeon removed the insert and found some cement debris on the tibial tray.The 8mm liner was deformed and for this a new liner 9mm was opened and implanted successfully.

• Brand Name: GMK UNI FIXED TIBIAL INSERT
• Type of Device: FIXED PE TIBIAL INSERT
• 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, 6874 ; SZ 6874
• MDR Report Key: 7142974
• MDR Text Key: 95724012
• Report Number: 3005180920-2017-00774
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030823909
• UDI-Public: 07630030823909
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Catalogue Number: 02.08.IF1.06.RMLL
• Device Lot Number: 168938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2017
• 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: 80 YR