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

Catalog Number	02.09.0214H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: KNEE TIBIAL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9563571
• Report Number: 3005180920-2019-01115
• Device Sequence Number: 13905743
• Product Code: KRO
• UDI-Device Identifier: 07630030825064
• UDI-Public: 07630030825064
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 02.09.0214H
• Device Lot Number: 163644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention