MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE TIBIAL INSERT - SIZE3 - 12 MM; KNEE TIBIAL INSERT

Catalog Number	02.09.0312H
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 february 2024: lot 1900723: (b)(4) items manufactured and released on 15-may-2019.Expiration date: 2024-05-01.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.
Event or Problem Description
The post screw had backed out of the poly.At 3 years and 8 months post primary (gmk hinge implanted during primary), the surgeon revised the patient by replacing the screw and the poly.The surgery was completed successfully.
Additional Manufacturer Narrative
During a random mdr check conducted on october 3, 2024, some errors were noticed.A follow-up is being initiated to correct them.Date received by manufacturer 06-feb-2024 (it was inserted on (b)(6) 2024); m.Us contact (it was inserted m.Au contact); k number (it was inserted in device bla field).

• Brand Name: GMK-HINGE TIBIAL INSERT - SIZE3 - 12 MM
• 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: 18817511
• Report Number: 3005180920-2024-00074
• Device Sequence Number: 4320122
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 10/09/2024

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: 05/01/2024
• Device Catalogue Number: 02.09.0312H
• Device Lot Number: 1900723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2019
• 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