MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FULL-PE UC TIBIAL COMPONENT SIZE 2/14

Model Number	02.07.0214APUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 january 2021: lot 1902012: (b)(4) items manufactured and released on 09-apr-2019.Expiration date: 2024-03-24.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been already sold without any other similar reported event.Additional device involved: batch review performed on 12 january 2021: gmk-primary 02.07.2003r femur std cemented size 3 r (k090988)lot.172883: (b)(4) items manufactured and released on 21-sep-2017.Expiration date: 2022-09-06.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.
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed washout and revised the full-pe uc tibial component and femoral component, 4 months after the primary.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY FULL-PE UC TIBIAL COMPONENT SIZE 2/14
• Common Device Name: FULL-PE UC TIBIAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11176899
• Report Number: 3005180920-2021-00047
• Device Sequence Number: 19432466
• Product Code: JWH
• UDI-Device Identifier: 07630030816642
• UDI-Public: 07630030816642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131310
• 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): 01/15/2021

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: 03/24/2024
• Device Model Number: 02.07.0214APUC
• Device Catalogue Number: 02.07.0214APUC
• Device Lot Number: 1902012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/15/2021
• 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