MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM; KNEE TIBIAL INSERT

Catalog Number 02.09.0423H

Device Problem Break (1069)

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

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on "2410" september 2019.Lot 143831: (b)(4) items manufactured and released on 22-sept-2014.Expiration date: 2019-07-30.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been already sold without any similar reported event.Clinical evaluation performed by medical affairs director two years after revision tka with constrained prosthesis the screw holding the pe insert is found to be broken, although the insert is regularly in place.Surgery is performed to replace the polyethylene component.The report does not say whether a new screw could be used.We cannot determine if the screw got broken at surgery or later on.Lack of information does not allow a fully meaningful analysis to be performed.There are no elements that let us understand how and why the screw fractured.

Event Description

The patient came in for a follow-up appointment and had x-rays taken.The surgeon observed that the screw that holds the tibial insert to the tibial tray was broken.Two years after primary surgery, the surgeon revised the poly and the broken screw.The patient did not complain of pain or discomfort before the revision surgery.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM
• Type of Device: KNEE 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9196343
• MDR Text Key: 173447956
• Report Number: 3005180920-2019-00856
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825231
• UDI-Public: 07630030825231
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2019
• Device Catalogue Number: 02.09.0423H
• Device Lot Number: 143831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2014
• 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