MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0410SF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 april 2024: lot 162471: (b)(4) items manufactured and released on 29-july-2016.Expiration date: 2021-07-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other 2 similar reported events during the period of review.Additional implants involved, batch review performed on 19 april 2024: gmk-primary 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 1904218: (b)(4) items manufactured and released on 03-oct-2019.Expiration date: 2024-10-19.No anomalies found related to the problem.To date, all the items of the same lot have been sold with another similar reported event during the period of review.Gmk-primary 02.07.2004l femur std cemented size 4 l (k090988) lot 1905179: (b)(4) items manufactured and released on 30-oct-2019.Expiration date: 2024-09-16.No anomalies found related to the problem.To date, (b)(4) the items of the same lot have been sold with another similar reported event during the period of review.Gmk-primary 02.07.0034rp patella resurfacing size 2 (k090988) lot 1902821: (b)(4) items manufactured and released on 25-jun-2019.Expiration date: 2024-06-10.No anomalies found related to the problem.To date, (b)(4) the items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
Revision surgery due to an infection and the pathogen is unknown.At about 4 years and 2 months post primary the surgeon removed all components, performed a washout, and reimplanted permanent hardware.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 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: 19236177
• Report Number: 3005180920-2024-00294
• Device Sequence Number: 8072184
• Product Code: JWH
• UDI-Device Identifier: 07630030817663
• UDI-Public: 07630030817663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/03/2024

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: 07/04/2021
• Device Catalogue Number: 02.07.0410SF
• Device Lot Number: 162471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2016
• 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 Sex: Male