MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM; FIXED KNEE TIBIAL INSERT

Model Number	02.07.0217FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 8 january 2021: lot 186262: 30 items manufactured and released on 19-oct-2018.Expiration date: 2023-10-08.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-primary 02.07.2013l femur cemented std size 3narrow / left (k122232) lot.146097 batch review performed on 8 january 2021: lot 146097: 35 items manufactured and released on 12-nov-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.Additional implant involved: gmk-primary 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot.144883 batch review performed on 8 january 2021: lot 144883: 24 items manufactured and released on 9-sep-2014.Expiration date: 2019-07-30.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event since 2017.
Event or Problem Description
6 months after the previous revision surgery patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.The 1st revision surgery was performed due to pain (the patient had a fall) and the liner 14mm was revised to 17 mm.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM
• Common Device Name: FIXED KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11228573
• Report Number: 3005180920-2021-00071
• Device Sequence Number: 3717880
• Product Code: JWH
• UDI-Device Identifier: 07630030816772
• UDI-Public: 07630030816772
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: 10/08/2023
• Device Model Number: 02.07.0217FUC
• Device Catalogue Number: 02.07.0217FUC
• Device Lot Number: 186262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/26/2021
• 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