MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM; KNEE FIXED TIBIAL INSERT

Catalog Number	02.09.0126H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 jul 2019: lot 162429: (b)(4) items manufactured and released on 12-may-2016.Expiration date: 19-04-2021.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any similar reported event.Additional implants involved in the event, batch review performed on 02 jul 2019.Gmk-hinge 02.09.4001l fixed tibial tray size 1 l (k130299) lot.154266.Lot 154266: (b)(4) items manufactured and released on 08-sep-2015.Expiration date: 31-07-2020.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 02.09.2602l femoral component size 2 l (k130299) lot.156526.Lot 156526: (b)(4) items manufactured and released on 15-mar-2016.Expiration date: 31-01-2021.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.Ta105 tibial augmentation size 1/5mm (k130299) lot.148082.Lot 148082: (b)(4) items manufactured and released on 03-jun-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.In this complaint two devices were involved with the same lot number.Gmk-hinge 02.07.Fcl14105 extension stem - fluted ø 14 l 105 (k120790) lot.164186.Lot 164186: (b)(4) items manufactured and released on 26-sep-2016.Expiration date: 30-08-2021.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 02.07.220fda femoral augmentation distal size 2/20mm (k163311 ) lot.161346.Lot 161346: (b)(4) items manufactured and released on 24-oct-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.(b)(4) items are present in this complaint with the same lot number.Gmk-hinge 02.07.Fcl15150 extension stem - fluted ø 15 l 150 (k120790) lot.155895.Lot 155895: (b)(4) items manufactured and released on 09-feb-2016.Expiration date: 20-01-2021.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 performed a washout and revised the poly, tibial tray, femoral component, augments and extension stems.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8784034
• Report Number: 3005180920-2019-00607
• Device Sequence Number: 19432480
• Product Code: KRO
• UDI-Device Identifier: 07630030825033
• UDI-Public: 07630030825033
• 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): 07/12/2019

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: 04/19/2021
• Device Catalogue Number: 02.09.0126H
• Device Lot Number: 162429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/12/2019
• 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