MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 6 R; KNEE REVISION FEMORAL COMPONENT

Catalog Number	02.09.2606R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 november 2023: lot 189376: (b)(4) on (b)(6) 2019.Expiration date: 2024-01-29.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Additional component involved in the event: gmk-hinge 02.09.0517uch uc fixed tibial insert size 5/17mm lot.183650: (b)(4) on 21-aug-2018.Expiration date: 2023-07-05.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.09.4005r fixed tibial tray size 5 r lot.187559: (b)(4) manufactured and released on 27-nov-2018.Expiration date: 2023-11-15.No anomalies found related to the problem.To date,(b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.09.Ta405 tibial augmentation size 4/5mm lot.171459: (b)(4) manufactured and released on 09-jun-2017.Expiration date: 2022-05-14.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.09.Ta405 tibial augmentation size 4/5mm lot.173056: (b)(4) manufactured and released on 06-oct-2017.Expiration date: 2022-09-19.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.05.06dw femoral wedge distal size 6/8mm lot.189632: (b)(4) manufactured and released on 08-apr-2019.Expiration date: 2024-03-25.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.05.06pw femoral wedge posterior size 6/5mm lot.142961a: (b)(4) manufactured and released on 18-sep-2019.Expiration date: 2024-09-03.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.07.Cs20 cono tibiale 3dmetal centrato s h20 lot.172466: (b)(4)manufactured and released on 30-apr-2018.Expiration date: 2023-04-09.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.07.Fsc13065 extension stem - cemented ø 13 l 65 lot.2000801: (b)(4)manufactured and released on 19-may-2020.Expiration date: 2025-05-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Gmk-hinge 02.07.Fsc16065 extension stem - cemented ø 16 l 65 lot.2004759: (b)(4) manufactured and released on 01-oct-2020.Expiration date: 2025-09-18.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
Revision surgery for knee infection at 2 years and 10 months from primary for knee infection.All devices were revised successfully and an antibiotic spacer was implanted successfully.
Additional Manufacturer Narrative
Follow-up reason: k number of the other components were not entered in the initial report.Gmk-hinge 02.09.0517uch uc fixed tibial insert size 5/17mm - k172347.Gmk-hinge 02.09.4005r fixed tibial tray size 5 r - k130299.Gmk-hinge 02.09.Ta405 tibial augmentation size 4/5mm - k130299.Gmk-hinge 02.09.Ta405 tibial augmentation size 4/5mm - k130299.Gmk-hinge 02.05.06dw femoral wedge distal size 6/8mm - k102437.Gmk-hinge 02.05.06pw femoral wedge posterior size 6/5mm - k102437.Gmk-hinge 02.07.Cs20 cono tibiale 3dmetal centrato s h20 - k170149.Gmk-hinge 02.07.Fsc13065 extension stem - cemented ø 13 l 65 - k120790.Gmk-hinge 02.07.Fsc16065 extension stem - cemented ø 16 l 65 - k120790.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 6 R
• Common Device Name: KNEE REVISION FEMORAL COMPONENT
• 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: 18316676
• Report Number: 3005180920-2023-00990
• Device Sequence Number: 6278255
• Product Code: KRO
• UDI-Device Identifier: 07630030825507
• UDI-Public: 07630030825507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 01/29/2024
• Device Catalogue Number: 02.09.2606R
• Device Lot Number: 189376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2019
• 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