MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL AUGMENTATION SIZE 4/5MM

Catalog Number	02.09.TA405
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 september 2019.Lot 162447: 24 items manufactured and released on 11-may-2016.Expiration date: 2021-04-24.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold with another similar reported event (reported in this complaint).Other devices involved in the event: gmk-revision 02.07.Fcl18105 extension stem - fluted ø 18 l 105 lot.172187 (k120790).Batch review performed on 12 september 2019.Lot 172187: 35 items manufactured and released on 12-jul-2017.Expiration date: 2022-07-02.No anomalies found related to the problem.To date, 27 items of the same lot have been already sold with another similar reported event.Gmk-revision 02.07.2404r femur revision ps size 4 r lot.172143 (k102437).Batch review performed on 12 september 2019.Lot 172143: 15 items manufactured and released on 31-jul-2017.Expiration date: 2022-07-12.No anomalies found related to the problem.To date, 11 items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.07.Fcl13105 extension stem - fluted ø 13 l 105 lot.162539 (k120790).Batch review performed on 12 september 2019.Lot 162539: 52 items manufactured and released on 26-jul-2016.Expiration date: 2021-07-04.No anomalies found related to the problem.To date, 41 items of the same lot have been already sold with another similar reported event.Gmk-revision 02.07.0684r revision fixed tibial tray cemented size 4 r lot.162506 (k123721).Batch review performed on 12 september 2019.Lot 162506: 30 items manufactured and released on 17-jun-2016.Expiration date: 2021-06-06.No anomalies found related to the problem.To date, 28 items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.07.404fdw femoral wedge distal size 4/4mm lot.162591 (k102437).Batch review performed on 12 september 2019.Lot 162591: 26 items manufactured and released on 26-jul-2016.Expiration date: 2021-07-03.No anomalies found related to the problem.To date, 19 items of the same lot have been already sold without any other similar reported event.Gmk-revision 02.07.404fdw femoral wedge distal size 4/4mm lot.103626 (k102437).Batch review performed on 12 september 2019.Lot 103626: 10 items manufactured and released on 12-nov-2010.Expiration date: 2021-07-03.To date, 6 items of the same lot have been already sold without any other similar reported event.3 devices have been re-sterilized and released on 17-jun-2016.Expiration date: 2021-05-23.(these is the re-sterilized lot involved in this case).To date, 1 items of the same lot have been already sold.1 device has been re-sterilized and released on 04-oct-2016.Expiration date: 2021-09-13.To date, all items of the same lot have been already sold.Gmk-revision 02.07.0410scf fixed tibial insert sc size 4/10mm lot.161786 (k103170).Batch review performed on 12 september 2019.Lot 161786: 10 items manufactured and released on 06-jun-2016.Expiration date: 2021-05-19.No anomalies found related to the problem.To date, 6 items of the same lot have been already sold with another similar reported event.Gmk-revision 02.07.0005 offset connector 5 mm lot.178309 (k102437).Batch review performed on 12 september 2019.Lot 178309: 35 items manufactured and released on 12-mar-2018.Expiration date: 2023-02-21.No anomalies found related to the problem.To date, 31 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and implanted an antibiotic spacer almost 1 year and 2 months after previous surgery.The surgery was completed successfully.

• Brand Name: GMK-REVISION TIBIAL AUGMENTATION SIZE 4/5MM
• Common Device Name: TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9150286
• Report Number: 3005180920-2019-00845
• Device Sequence Number: 2810962
• Product Code: KRO
• UDI-Device Identifier: 07630030825712
• UDI-Public: 07630030825712
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: 04/24/2021
• Device Catalogue Number: 02.09.TA405
• Device Lot Number: 162447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 10/03/2019
• 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