MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM

Catalog Number	02.07.0214SCF
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.The patient had a primary right knee on (b)(6) 2017.The patient came in due to signs of infection.The pathogen was unknown.On (b)(6) 2017 another surgeon removed the implants and implanted an antibiotic spacer.On (b)(6) 2017 the revising surgeon performed the second step of the step-wise revision.On (b)(6) 2017, the patient came in again complaining of pain due to infection.Batch review performed on 30 october 2017.Lot 167083: (b)(4) items manufactured and released on 01 february 2017.Expiration date: 2022-01-10.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 due to infection.The pathogen is unknown at this time.The poly has been exchanged.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6990447
• Report Number: 3005180920-2017-00635
• Device Sequence Number: 13575193
• Product Code: JWH
• UDI-Device Identifier: 07630030816710
• UDI-Public: 07630030816710
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

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: 01/10/2022
• Device Catalogue Number: 02.07.0214SCF
• Device Lot Number: 167083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/31/2017
• 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