MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM L

Catalog Number 02.12.0310FL

Device Problem Device Slipped (1584)

Patient Problem Unspecified Infection (1930)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs department early infection in cemented tka, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch review performed on 22.Nov.2019: lot 1903249: 120 items manufactured and released on 03-jul-2019.Expiration date: 19/06/2024.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any other similar reported event.

Event Description

Revision surgery performed due to signs of infection and patella bone subluxation.The surgeon revised the inlay and performed an i&d.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/10 MM L
• Type of Device: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9416400
• MDR Text Key: 169608112
• Report Number: 3005180920-2019-01029
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826337
• UDI-Public: 07630030826337
• Combination Product (y/n): N
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/05/2019

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: 02.12.0310FL
• Device Lot Number: 1903249
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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 Age: 72 YR
• Patient Weight: 80