MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE EXTENSION STEM - FLUTED Ø 18 L 105; KNEE EXTENSION STEM

Catalog Number	02.07.FCL18105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to via falsa of the extension stem femoral component at 2 weeks from the primary.Femoral bone perforation is visible from the x-rays.Poor bone quality.All femoral components and inlay were successfully revised.
Additional Manufacturer Narrative
Batch review performed on 11 march 2024.Lot 2107123: (b)(4) items manufactured and released on 09-sept-2021.Expiration date: 2026-08-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department.Few days after a constrained tka surgery, the femoral part of the implant had to be exchanged because of faulty position.This was most probably due to the very bad bone quality, as a via falsa was followed when positioning the femoral stabilization stem.It is not known what led to the implantation of the first constrained tka, from the images received we can see that it is a difficult situation with sequelae of trauma and a tha in place.No reason to suspect a faulty device.

• Brand Name: GMK-HINGE EXTENSION STEM - FLUTED Ø 18 L 105
• Common Device Name: KNEE EXTENSION STEM
• 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: 19048600
• Report Number: 3005180920-2024-00209
• Device Sequence Number: 12898839
• Product Code: JWH
• UDI-Device Identifier: 07630030823060
• UDI-Public: 07630030823060
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2026
• Device Catalogue Number: 02.07.FCL18105
• Device Lot Number: 2107123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown