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

Model Number	02.09.4004L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 18 march 2020: lot 181161: (b)(4) items manufactured and released on 17-may2018.Expiration date: 2023-05-06.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.Additional components involved in the event, batch review performed on 18 march 2020: gmk-hinge 02.09.2604l femoral component size 4 l (k130299).Lot 182049: (b)(4) items manufactured and released on 25-jun-2018.Expiration date: 2023-05-24.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 02.05.04pw femoral wedge posterior size 4/5mm (k102437).Lot 177676: (b)(4) items manufactured and released on 16-jan-2018.Expiration date: 2023-01-04.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any other similar reported event.Gmk-hinge 02.09.0412h fixed tibial insert size 4/12mm (k130299).Lot 181587: (b)(4) items manufactured and released on 25-may-2018.Expiration date: 2023-05-06.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 (k120790).Lot 169010: (b)(4) items manufactured and released on 29-mar-2017.Expiration date: 2022-03-19.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.Gmk-hinge 02.07.404fdw femoral wedge distal size 4/4mm (k102437).Lot 174965: (b)(4) items manufactured and released on 22-nov-2017.Expiration date: 2022-10-30.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 02.07.404fdw femoral wedge distal size 4/4mm (k102437).Lot 171396: (b)(4) items manufactured and released on 22-jun-2017.Expiration date: 2022-05-22.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 02.05.04pw femoral wedge posterior size 4/5mm (k102437).Lot 172200: (b)(4) items manufactured and released on 12-jul-2017.Expiration date: 2022-07-02.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.Fcl20105 extension stem - fluted ø 20 l 105 (k120790).Lot 162554: (b)(4) items manufactured and released on 15-sep-2016.Expiration date: 2021-08-29.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 02.07.0005 offset connector 5 mm (k102437).Lot 178309: (b)(4) items manufactured and released on 12-mar-2018.Expiration date: 2023-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
Revision surgery performed after 1 year and 7 months after the primary due to an infection.The surgeon revised all implants, done a washout and installed a cement spacer.The pathogen is unknown.

• Brand Name: GMK-HINGE FIXED TIBIAL TRAY SIZE 4 L
• Common Device Name: FIXED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9932776
• Report Number: 3005180920-2020-00218
• Device Sequence Number: 19771047
• Product Code: KRO
• UDI-Device Identifier: 07630030825576
• UDI-Public: 07630030825576
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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: 05/06/2023
• Device Model Number: 02.09.4004L
• Device Catalogue Number: 02.09.4004L
• Device Lot Number: 181161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/07/2020
• 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