MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 20 MM; TIBIAL INSERT FIXED

Model Number	02.07.0520FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 july 2020: lot 151313: (b)(4) items manufactured and released on 08-oct-2015.Expiration date: 2020-09-22.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 since 2016.Other device involved in the event: gmk-primary 02.07.2005r femur std cemented # 5 r lot.171913 (k090988).Batch review performed on 16 july 2020: lot 171913: (b)(4) items manufactured and released on 28-aug-2017.Expiration date: 2022-08-15.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 an infection and the pathogen is unknown.The surgeon performed a washout and removed femur and liner (only medacta devices involved).An antibiotic spacer was implanted and the surgery was completed successfully 1 year after primary.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 20 MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10366567
• Report Number: 3005180920-2020-00490
• Device Sequence Number: 16730556
• Product Code: JWH
• UDI-Device Identifier: 07630030818615
• UDI-Public: 07630030818615
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: No Information
• Device Expiration Date: 09/22/2020
• Device Model Number: 02.07.0520FUC
• Device Catalogue Number: 02.07.0520FUC
• Device Lot Number: 151313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/05/2020
• 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