MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/17MM; KNEE TIBIAL INSERT

Model Number 02.09.0217H

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 september 2022.Lot 181575: (b)(4) items manufactured and released on 28-june-2018.Expiration date: 2023-06-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs director: approximately 6 months after implantation of a constrained tka, the radiographic control shows a broken insert screw.According to report, the patient reports pain, but it is not clear how and if such pain is related to the broken screw: the xray image, of very poor quality, shows radiolucency in the tibia near the implant, which in our opinion is a more probable cause of pain that will likely require revision.The size of the wedges under the tibial plateau is possibly too small, and there may be insufficient cortical contact.No xray history was supplied to try to understand when the fracture of the screw took place, therefore we cannot determine the causes for the adverse event.Most probably, the tibial component needs to be revised independently from the fractured screw.

Event Description

The patient came in for a post-op appointment at about 6 months after the primary and the x-rays indicated that the fixation screw of the gmk-hinge tibial insert was broken.During the primary surgery, the insert screw was tightened successfully using a 3nm torque.Revision surgery not yet performed.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/17MM
• Type of Device: KNEE TIBIAL INSERT
• 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: 15483656
• MDR Text Key: 300585724
• Report Number: 3005180920-2022-00730
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825071
• UDI-Public: 07630030825071
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: 02.09.0217H
• Device Catalogue Number: 02.09.0217H
• Device Lot Number: 181575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2018
• 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