MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 2 L; CEMENTED FEMORAL COMPONENT

Model Number	02.09.2602L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: delayed infection in hinged total knee arthroplasty, 4 months after implantation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Preliminary investigation performed by r&d manager: revision surgery of a gmk hinge implant after 4 months from primary implantation due to infection.Pictures of the explanted components have been sent for investigation.No anomalies can be noted on explanted components.Infection is a known possible adverse event following every surgery, including tka's.There is no reason to suspect that the event is related to the device.Batch review performed on 28 may 2021: lot 189366: (b)(4) items manufactured and released on 12-apr-2019.Expiration date: 2024-02-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved: batch reviews performed on 28 may 2021: gmk-hinge 02.09.0314h fixed tibial insert size 3/14mm (k130299) lot 1810690: (b)(4) items manufactured and released on 13-may-2019.Expiration date: 2024-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge 02.09.4003l fixed tibial tray size 3 l (k130299) lot 1906383: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge 02.07.204fdw femoral wedge distal size 2/4mm (k102437) lot 1908414: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge 02.07.Fcl13065 extension stem - fluted ø 13 l 65 (k120790) lot 1902929: (b)(4) items manufactured and released on 19-july-2019.Expiration date: 2024-07-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge 02.07.0005 offset connector 5 mm (k102437) lot 2000828: (b)(4) items manufactured and released on 04-june-2020.Expiration date: 2025-05-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge 02.07.Fcl18065 extension stem - fluted ø 18 l 65 (k120790) lot 1900655: (b)(4) items manufactured and released on 17-june-2019.Expiration date: 2024-06-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-hinge 02.07.204fdw femoral wedge distal size 2/4mm (k102437) lot 1904844: (b)(4) items manufactured and released on 04-oct-2019.Expiration date: 2024-09-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
4 months after medacta devices implantation revision surgery for infection.The pathogen is unknown.The surgeon removed all the implants.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 2 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12009447
• Report Number: 3005180920-2021-00486
• Device Sequence Number: 4543694
• Product Code: KRO
• UDI-Device Identifier: 07630030825415
• UDI-Public: 07630030825415
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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: 02/18/2024
• Device Model Number: 02.09.2602L
• Device Catalogue Number: 02.09.2602L
• Device Lot Number: 189366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 74