MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 3DMETAL TIBIAL TRAY SIZE 4L; KNEE TIBIAL TRAY

Catalog Number 02.12.3D04L

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2024

Event Type  Injury  

Event Description

At about 2 months after primary, the patient has been revised because of tibial baseplate subsidence.All the components have been revised to a semi-constrained system.The cause of the subsidence is unknown, but the surgeon expressed the opinion that bone quality was poor for a 3d metal implant.In the primary surgery was used the ka surgical technique, while ma has been used during revision surgery.

Manufacturer Narrative

Batch review performed on 29-jan-2024 lot 2115254: 33 items manufactured and released on 27-jan-2022.Expiration date: 2027-01-16.No anomalies found related to the problem.To date, 30 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department two months after primary cementless tka the bone supporting the tibial baseplate collapses and the whole system requires revision.It was revised to a cemented, semi-constrained prosthesis, probably more suitable for the bone quality and the anaytomical configuration of this patient.The cause for this reoperation is to be sought in bone quality and possibly undersizing of the femoral component, we see no reason to suspect a faulty device.

• Brand Name: GMK-SPHERE 3DMETAL TIBIAL TRAY SIZE 4L
• Type of Device: KNEE TIBIAL TRAY
• 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: 18675943
• MDR Text Key: 335011818
• Report Number: 3005180920-2024-00050
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221850
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.12.3D04L
• Device Lot Number: 2115254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2022
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White