MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.2604L FEMORAL COMPONENT SIZE 4 L; KNEE FEMORAL COMPONENT

Model Number 02.09.2604L

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 may 2022: (b)(4).Clinical evaluation performed by medical affairs director: few weeks after revision tka ina very heavy patient, a femoral fracture occurs and the femoral component inevitably migrates.Exchange of the femoral component and the habitual replacement of the pe insert is performed after stabilizing the fracture.This adverse event is not due to a faulty device.

Event Description

Revision surgery 1 month after primary for femoral fracture and successive subsidence of the femoral component.Insert and femur revised successfully.

• Brand Name: GMK-HINGE 02.09.2604L FEMORAL COMPONENT SIZE 4 L
• Type of Device: KNEE FEMORAL COMPONENT
• 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: 14733582
• MDR Text Key: 294282413
• Report Number: 3005180920-2022-00468
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825453
• UDI-Public: 07630030825453
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130299
• 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: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.2604L
• Device Catalogue Number: 02.09.2604L
• Device Lot Number: 2001378
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2020
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic