MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/23MM; KNEE TIBIAL INSERT

Model Number	02.07.0223SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 8 may 2020: lot 186421: (b)(4) items manufactured and released on 25-oct-2018.Expiration date: 2023-10-10.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 devices involved: batch reviews performed by medacta regulatory affairs department on 8 may 2020: gmk-revision 02.07.2403r femur revision ps #3 r (k102437) lot 178497: (b)(4) items manufactured and released on 9-feb-2018.Expiration date: 2023-01-03.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-revision 02.07.0682r revision fixed tibial tray cemented size 2 r (k123721) lot 162504: (b)(4) items manufactured and released on 28-jun-2016.Expiration date: 2021-06-12.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-sphere 02.12.0005l femoral component sphere cemented size 5 (k121416) lot 171004: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-11.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-sphere 02.12.0520fl tibial insert fixed sphere flex size 5/20 mm l (k121416) lot 175249: (b)(4) items manufactured and released on 9-nov-2017.Expiration date: 2022-10-18.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
Revision surgery performed due to infection in the right and left knee (the pathogen is unknown).The surgeon revised all implants and implanted an antibiotic spacer in both knees.Previously this patient had several revision surgeries (5th for the right knee and 3rd for the left knee).The reason for the previous revision is unknown beside the 4th revision of the right knee when the patient had a fall and ruptured extensor mechanism.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/23MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10086355
• Report Number: 3005180920-2020-00294
• Device Sequence Number: 2561842
• Product Code: JWH
• UDI-Device Identifier: 07630030816970
• UDI-Public: 07630030816970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 10/10/2023
• Device Model Number: 02.07.0223SCF
• Device Catalogue Number: 02.07.0223SCF
• Device Lot Number: 186421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/26/2020
• 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