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

Catalog Number	02.09.2602R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 jun 2019.Lot 162147: (b)(4) items manufactured and released on 09-may-2016.Expiration date: 20-04-2021.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 implants involved in the event, batch review performed on (b)(6) 2019.Gmk-hinge 02.07.216fda femoral augmentation distal size 2/16mm (k163311) lot.161349 lot 161349: (b)(4) items manufactured and released on 24-oct-2016.Expiration date: 21-04-2020.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.Two items with the same lot are reported in this event.Gmk-hinge 02.07.Fcl15150 extension stem - fluted ø 15 l 150 (k120790), lot.162546.Lot 162546: (b)(4) items manufactured and released on 25-aug-2016.Expiration date: 27-07-2021.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 02.09.4001r fixed tibial tray size 1 r (k130299), lot.164808.Lot 164808: (b)(4) items manufactured and released on 07-sep-2016.Expiration date: 28-08-2021.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 02.09.0120h fixed tibial insert size 1/20mm (k130299), lot.161838.Lot 161838: (b)(4) items manufactured and released on 12-apr-2016.Expiration date: 28-03-2021.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold.Gmk-hinge 02.09.Ta110 tibial augmentation size 1/10mm (k130299), lot.123243.Lot 123243: (b)(4) items manufactured and released on 24-jan-2013.Expiration date: 31-12-2017.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Gmk-hinge 02.09.Ta110 tibial augmentation size 1/10mm (k130299), lot.148083.Lot 148083: (b)(4) items manufactured and released on 07-jul-2015.Expiration date: 31-03-2020.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.Fcl13105 extension stem - fluted ø 13 l 105 (k120790), lot.162539.Lot 162539: (b)(4) items manufactured and released on 26-jul-2016.Expiration date: 04-07-2021.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
The patient came in, two years after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and implanted an antibiotic spacer and the surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 2 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8744216
• Report Number: 3005180920-2019-00522
• Device Sequence Number: 1342074
• Product Code: KRO
• UDI-Device Identifier: 07630030825422
• UDI-Public: 07630030825422
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 04/20/2021
• Device Catalogue Number: 02.09.2602R
• Device Lot Number: 162147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/28/2019
• 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