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

Catalog Number 02.07.0217SCF

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 01/16/2024

Event Type  Injury  

Event Description

The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2022, the patient came in for a post-op appointment with a loose knee femur and overstretched mcl and the cause is unknown.The surgeon revised the femur and added some varus alignment and used semi-constrained for stability.The surgery was completed successfully.On (b)(6) 2024, the patient came in reporting knee instability and the cause is unknown.The surgeon upsized the insert, revised the tibial tray and the surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 06 february 2024: lot 2008656: (b)(4) manufactured and released on 16-apr-2021.Expiration date: 2025-09-02.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional device involved batch review performed on 06 february 2024: gmk-revision 02.07.1202l fixed tibial tray cemented size 2 l (k090988) lot 2002923: (b)(4) manufactured and released on 15-july-2020.Expiration date: 2025-07-06.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Same patient of mdr 3005180920-2022-00432.Ethnicity and race added in this mdr.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18648849
• MDR Text Key: 334612762
• Report Number: 3005180920-2024-00040
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103170
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.07.0217SCF
• Device Lot Number: 02.07.0217SCF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/16/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American