MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM; KNEE FIXED TIBIAL INSERT

Model Number 02.09.0417H

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

Patient Problem Joint Laxity (4526)

Event Date 01/30/2023

Event Type  Injury  

Event Description

At about 4 years 10 months after the primary, the patient came in reporting pain due to stiffness.The surgeon resurfaced the patient's natural patella and downsized the insert (17 to 14 mm).The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 06 february 2023.Lot 161908: (b)(4) items manufactured and released on 08-apr-2016.Expiration date: 2021-03-28.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.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16459845
• MDR Text Key: 310424680
• Report Number: 3005180920-2023-00105
• Device Sequence Number: 1
• Product Code: KRO
• 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: 03/01/2023

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 Expiration Date: 03/28/2021
• Device Model Number: 02.09.0417H
• Device Catalogue Number: 02.09.0417H
• Device Lot Number: 161908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• 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