MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/12MM; KNEE TIBIAL INSERT

Catalog Number	02.09.0212H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 10 june 2024: lot 2215591:(b)(4) items manufactured and released on 18-aug-2022.Expiration date: 2027-jul-25.No anomalies found related to the problem.To date, 5 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: a few months after a complex revision tka with a constrained device, the screw that joins the femoral component with the tibial tray is found broken.This is a very unusual finding; it's a rather large screw and it is not subject, during the implant life, to particular stresses.It is conceivable that the fracture took place, or it was initiated, during surgery, at the time of tightening, but the mechanism that may have led to screw breakage is totally unclear.It's possible that a third body may have been trapped in a position that changed the stress pattern of the screw during operation, otherwise, it's very difficult to imagine that such a fracture could occur.The consequence was a quick reoperation to change the post; no repositioning of the components was required.
Event or Problem Description
Revision surgery performed due to hinge post screw breakage about 7 months after the primary surgery.Only the post was revised.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/12MM
• Common Device Name: 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: 19519655
• Report Number: 3005180920-2024-00413
• Device Sequence Number: 6425213
• Product Code: KRO
• UDI-Device Identifier: 07630030825057
• UDI-Public: 07630030825057
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.09.0212H
• Device Lot Number: 2215591
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2022
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White