MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/26MM

Catalog Number 02.09.0426H

Device Problem Break (1069)

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

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on (b)(6) 2018: lot 135270: 14 items manufactured and released on (b)(6)2014.Expiration date: (b)(6) 2018.No anomalies found related to the issue.To date, 2 items of the same lot have been already sold without any similar reported event.

Event Description

This patient had a hinge revised due to a screw breakage in (b)(6) 2018.The revision was completed successfully however the screw has broken again.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/26MM
• Type of Device: FIXED 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: 8069023
• MDR Text Key: 129166718
• Report Number: 3005180920-2018-00915
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825248
• UDI-Public: 07630030825248
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 02.09.0426H
• Device Lot Number: 135270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2014
• 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): Other
• Patient Age: 61 YR