MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R

Model Number	02.09.4004R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2020: lot 1907619: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-12-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: gmk-hinge 02.09.2604r femoral component size 4 r lot.1904680 (k130299).Batch review performed on 08 october 2020: lot 1904680: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-07.No anomalies found related to the problem.To date, xx items of the same lot have been already sold without any other similar reported event.Gmk-hinge 02.09.0420h fixed tibial insert size 4/20mm lot.1900730 (k130299).Batch review performed on 08 october 2020: lot 1900730: (b)(4) items manufactured and released on 07-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-hinge 02.07.Fcl16065 extension stem - fluted ø 16 l 65 lot.1902936 (k120790).Batch review performed on 08 october 2020: lot 1902936: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-hinge 02.07.Fcl13065 extension stem - fluted ø 13 l 65 lot.1905619 (k120790).Batch review performed on 08 october 2020: lot 1905619: (b)(4) items manufactured and released on 13-nov-2019.Expiration date: 2024-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk hinge 02.07.0003 offset connector 3 mm lot.1909718 (k102437).Batch review performed on 08 october 2020: lot 1909718: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-hinge 02.07.0034rp patella resurfacing size 2 lot.1908302 (k090988).Batch review performed on 08 october 2020: lot 1908302: (b)(4) items manufactured and released on 07-nov-2019.Expiration date: 2024-10-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation: revision surgery after 1 month from implantation due to infection of a gmk hinge implant.Picture of the explanted components doesn't revealed any anomalies.Cause for infection remains unknown.There is no evidence that the event is related to a faulty device.Clinical evaluation: early infection in hinged tka, few weeks after primary operation.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.
Event or Problem Description
Revision surgery following an infection performed on the (b)(6) 2020, 1 month after primary.All devices explanted.The surgery was completed successfully.
Additional Manufacturer Narrative
Other devices involved in the event.Batch review performed on 08 october 2020: gmk-hinge 02.09.2604r femoral component size 4 r lot.1904680 (k130299): (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

• Brand Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R
• Common Device Name: FIXED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10755289
• Report Number: 3005180920-2020-00761
• Device Sequence Number: 1138696
• Product Code: KRO
• UDI-Device Identifier: 07630030825583
• UDI-Public: 07630030825583
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 12/16/2024
• Device Model Number: 02.09.4004R
• Device Catalogue Number: 02.09.4004R
• Device Lot Number: 1907619
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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 Age: 61 YR
• Patient Weight: 80