MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0412SCF
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.The patient had a primary knee on (b)(6) 2015.On (b)(6) 2015 the patient came in due to signs of infection.Then, the patient came in complaining of pain.Batch review performed on 13 november 2017.Lot 134045: (b)(4) items manufactured and released on 13 november 2013.Expiration date: 2018-09-30.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 complaining of pain.The surgeon was unable to determine the cause of pain.The surgeon swapped the poly.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7037279
• Report Number: 3005180920-2017-00663
• Device Sequence Number: 1013603
• Product Code: JWH
• UDI-Device Identifier: 07630030817755
• UDI-Public: 07630030817755
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: 09/30/2018
• Device Catalogue Number: 02.07.0412SCF
• Device Lot Number: 134045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/16/2017
• 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
• Patient Age: 53 YR