MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R; KNEE FEMUR

Model Number	02.07.4404R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01-jun-2023.Lot 2102183: 8.(b)(4) additional devices involved, batch review performed on 01-jun-2023: gmk-revision 02.07.0410scf fixed tibial insert sc size 4/10mm (k103170) lot.185114 lot 185114: 25 items manufactured and released on 20-sep-2018.Expiration date: 2023-08-30.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported case during the period of review.Gmk-revision 02.07.4684r tinbn coated revision tibial tray size 4 right (k210010) lot.2006119 lot 2006119: 6 items manufactured and released on 15-dec-2020.Expiration date: 2025-12-01.No anomalies found related to the problem.To date, 4 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 1 year and 5 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised successfully all the components.The primary medacta surgery was a revision of the competitor components.

• Brand Name: GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R
• Common Device Name: KNEE FEMUR
• 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: 17169971
• Report Number: 3005180920-2023-00451
• Device Sequence Number: 6574843
• Product Code: JWH
• UDI-Device Identifier: 07630971258006
• UDI-Public: 07630971258006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K210010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 06/21/2023

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: 03/29/2026
• Device Model Number: 02.07.4404R
• Device Catalogue Number: 02.07.4404R
• Device Lot Number: 2102183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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: Male