MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM; KNEE FIXED TIBIAL INSERT

Catalog Number 02.09.0523H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 09/08/2023

Event Type  Injury  

Event Description

The patient came in for a post-op appointment and it was observed that the patient had a hyper-extended medacta hinge knee and the cause is unknown.No revision scheduled at this time.

Manufacturer Narrative

Batch review performed on (b)(6) 2023.Lot 189424: 20 items manufactured and released on 20-feb-2019.Expiration date: 2024-02-10.No anomalies found related to the problem.To date, 4 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-hinge 02.09.2606l femoral component size 6 l (k130299) lot.1908921: 14 items manufactured and released on 27-feb-2020.Expiration date: 2025-02-15.No anomalies found related to the problem.To date, 5 items of the same lot have been sold with no similar reported event during the period of review.Gmk-hinge 02.09.4005l fixed tibial tray size 5 l (k130299) lot 1907623: 7 items manufactured and released on 15-jan-2020.Expiration date: 2025-01-06.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM
• Type of Device: KNEE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17886291
• MDR Text Key: 325090443
• Report Number: 3005180920-2023-00783
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825309
• UDI-Public: 07630030825309
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.09.0523H
• Device Lot Number: 189424
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2019
• 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
• Patient Sex: Male