MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM

Catalog Number	02.09.0314H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.She had a primary using non-medacta product.On (b)(6) 2017 the patient was revised and had medacta product implanted as part of an antibiotic spacer.On (b)(6) 2017 the surgeon removed all medacta components and implanted permanent product.In august 2017 the patient came in due to signs of infection.Batch review performed on (b)(6) 2017.Lot 161840: (b)(4) items manufactured and released on 08 april 2016.Expiration date: 2021-03-28.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
The patient came in due to signs of infection.The pathogen is unknown.The surgeon revised the insert.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6847606
• Report Number: 3005180920-2017-00492
• Device Sequence Number: 11143536
• Product Code: KRO
• UDI-Device Identifier: 07630030825132
• UDI-Public: 07630030825132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: 03/28/2021
• Device Catalogue Number: 02.09.0314H
• Device Lot Number: 161840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• 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