MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM; KNEE FIXED TIBIAL INSERT

Catalog Number	02.07.0414SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 may 2019: lot 174957: (b)(4) items manufactured and released on 16-jan-2018.Expiration date: 2022-12-17.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 had a primary tka on (b)(6) 2017.She came in due to signs of infection and the pathogen was unknown.The surgeon subsequently revised the femoral component, poly and performed a washout on (b)(6) 2019 and complaint (b)(4) was filed.Presently, two months after primary surgery, the patient came in again due to signs of infection and the pathogen is unknown.The surgeon performed a washout and poly swap.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8595277
• Report Number: 3005180920-2019-00352
• Device Sequence Number: 11336126
• Product Code: JWH
• UDI-Device Identifier: 07630030817878
• UDI-Public: 07630030817878
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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: 12/17/2022
• Device Catalogue Number: 02.07.0414SCF
• Device Lot Number: 174957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/09/2019
• 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