MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM; KNEE TIBIAL AUGMENT

Model Number	02.09.TA210
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 june 2023: lot 1910561: (b)(4) items manufactured and released on 05-feb-2020.Expiration date: 2025-01-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional device involved: batch reviews performed on 12 june 2023: gmk-revision 02.07.10.3502 revision trial tibial spacer size 2 lot 1412518: (b)(4) items manufactured and released on 03-dec-2014.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Batch review performed on 12 june 2023 gmk-revision 02.07.Es20 eccentric 3dmetal tibial cone s h20 (k170149) lot 186775: (b)(4) items manufactured and released on 21-mar-2019.Expiration date: 2024-03-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Investigation on the pictures received performed by medacta knee r&d project manager: even if the trial tibial augments have the external shape and dimension a little different than the final implant (difference justified by the need to reduce the number of trial device to be used during the surgery), the surgeon tried to implant an eccentric cone in combination with tibial augtment.This combination is not permitted as described into the specific tibial cones surgical technique.The case has to be considered an out of label procedure.
Event or Problem Description
During the knee revision of a competitor's implants and while trialing for the augment, it was observed that the dimensional profile of the trial augment was not the same as the actual augment implant.The eccentric cone could be coupled to the augment trial, while the implant could not.The surgeon utilized a metal cutting wheel to cut the eccentric cone, in order for the augment to fit.There was a 30-minute delay in the case and the surgery was completed successfully.Note that augment should not be coupled with the cone, this is an off label use.

• Brand Name: GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM
• Common Device Name: KNEE TIBIAL AUGMENT
• 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: 17190147
• Report Number: 3005180920-2023-00469
• Device Sequence Number: 20667220
• Product Code: KRO
• UDI-Device Identifier: 07630030825682
• UDI-Public: 07630030825682
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/23/2023

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 Expiration Date: 01/22/2025
• Device Model Number: 02.09.TA210
• Device Catalogue Number: 02.09.TA210
• Device Lot Number: 1910561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2023
• 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 Sex: Female