MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL TRAY SIZE 3 LEFT - FINISHING; KNEE TIBIAL TRAY

Catalog Number	02.07.0683L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had shin pain and the cause was unknown.At about 1 year and 1 month post primary the surgeon revised the tibial tray, insert, augments and extension stem.The surgery was completed successfully.Notes: patient expressed shin pain from the 11x150 stem extension.The original tibial component with tibial augments, and stem extension were removed.A short stem extension was utilized with original size augments was used.
Additional Manufacturer Narrative
Batch review performed on 3 july 2024 lot 2215011: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-09-27.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.Additional implants revised batch review performed on 3 july 2024 on gmk-revision 02.07.0310scf fixed tibial insert semiconstrained s.3 / 10 mm (k103170) lot.2010895 lot 2010895: (b)(4) items manufactured and released on 22-jan-2021.Expiration date: 2025-12-29.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.Batch review performed on 3 july 2024 on gmk-revision 02.07.Fcl12150 fluted extension stem ø12mm / l 150mm (k120790) lot.189576 lot 189576: (b)(4) items manufactured and released on 28-jan-2019.Expiration date: 2024-01-14.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.Batch review performed on 3 july 2024 on gmk-revision 02.09.Ta305 tibial augmentation screwed s3 - 5 mm (k130299) lot.2240424 lot 2240424: (b)(4) items manufactured and released on 06-dec-2022.Expiration date: 2027-11-22.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.Batch review performed on 3 july 2024 on gmk-revision 02.09.Ta310 tibial augmentation screwed s3 - 10 mm (k130299) lot.2109504 lot 2109504: (b)(4) items manufactured and released on 19-oct-2021.Expiration date: 2026-10-03.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.

• Brand Name: GMK-REVISION TIBIAL TRAY SIZE 3 LEFT - FINISHING
• Common Device Name: KNEE TIBIAL TRAY
• 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: 19826861
• Report Number: 3005180920-2024-00547
• Device Sequence Number: 8666280
• Product Code: JWH
• UDI-Device Identifier: 07630030819360
• UDI-Public: 07630030819360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123721
• 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): 07/25/2024

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 Catalogue Number: 02.07.0683L
• Device Lot Number: 2215011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2022
• 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: Required Intervention
• Patient Sex: Female