MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM; KNEE TIBIAL INSERT

Catalog Number	02.09.0312H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2023.Lot 165129: (b)(4) items manufactured and released on 26-oct-2016.Expiration date: 2021-oct-12.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 r&d manager: 4.5 years after a difficult tka with a constrained cemented device in a severe valgus patient, the inlay fixation screw is found broken.We have no information as to the clinical status of the patient.The screw fragment seem to have moved in a position that is at the moment harmless, but removal would be strongly advisable - it's also a very short and probably harmless operation, but of course the surgeon will evaluate this against the general conditions of the patient.Also, the surgeon will assess if removal of the tibial tray is absolutely mandatory.This should be done only if the insert is now loose and depending on the activity level of the patient.The severe valgus of the patient knee may have contributed to creating a stress situation that favoured the fracture of the screw, although this is not a contraindicated case for a constrained prosthesis.
Event or Problem Description
About 4 years and 7 months after the primary surgery, the inlay locking screw was found broken.Revision surgery is planned on (b)(6) 2023.The patient has a neurological gait disorder and it is suspected that this has resulted in strong lever forces.
Event or Problem Description
About 4 years and 7 months after the primary surgery, the inlay locking screw was found broken.Revision planned for (b)(6) 2024.The patient has a neurological gait disorder and it is suspected that this has resulted in strong lever forces.
Additional Manufacturer Narrative
On 2 dec 2023, the hospital informed us that the revision surgery had been postponed and had been planned for (b)(6) 2024.In the event description reported to in the mdr 2023-00771 it was written that the revision was planned for (b)(6) 2023.
Event or Problem Description
About 4 years and 7 months after the primary surgery, the inlay locking screw was found broken.The patient has a neurological gait disorder and it is suspected that this has resulted in strong lever forces.Revision was planned for (b)(6) 2024 but it was not performed due to patient's problems.No other information is available and revision has not been scheduled.
Additional Manufacturer Narrative
Info received by the branch on 4 march 2024: revision was planned for (b)(6) 2024 but was not performed because the patient can't be operated at the moment.Revision has not been scheduled.B1: product problem (e.G., defects/malfunctions) is 'yes'.

• Brand Name: GMK-HINGE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM
• 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: 17919800
• Report Number: 3005180920-2023-00771
• Device Sequence Number: 19575958
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2021
• Device Catalogue Number: 02.09.0312H
• Device Lot Number: 165129
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023; 09/12/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/20/2023; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2016
• 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 Age: 70 YR
• Patient Sex: Male