MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM KNEE TIBIAL LINER

Catalog Number 02.09.0214H

Device Problems Loose or Intermittent Connection (1371); Unstable (1667)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 03-jan-2020: lot 163644: (b)(4) items manufactured and released on 28-sep-2016. Expiration date: 31. 08. 2021. 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: almost 3 years after revision tka with a constrained device, the screw that connects the femoral component to the rotating post is found loose in the joint at xray examination. Surgery is undertaken and the screw is replaced. The insert is also exchanged, out of standard practice in similar circumstances. The reason for the spontaneous back-out of the screw cannot be determined with the information at hand. One possible mechanical explanation is insufficient tightening torque at primary surgery, but other causes may also play a role. No clinical cause for the event can be identified and no further clinical consequences should be expected.

Event Description

The patient came in complaining of instability due to a loose gmk hinge post screw 2 years and 9 months after primary. The surgeon was able to remove the screw and he also performed a poly swap. The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
• Type of Device: KNEE TIBIAL LINER
• 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: 9563571
• MDR Text Key: 216652593
• Report Number: 3005180920-2019-01115
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 02.09.0214H
• Device Lot Number: 163644
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/08/2020 Patient Sequence Number: 1