MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED # 4 / 17 MM; KNEE TIBIAL INSERT FIXED

Catalog Number	02.07.0417FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.She had a primary right knee on (b)(6) 2016.The patient came in due to signs of infection.On (b)(6) 2017 all medacta hardware was revised and a spacer was implanted.On (b)(6) 2017 the surgeon revised the antibiotic spacer as planned, and reimplanted medacta product.The surgery was completed successfully.Then, the patient came in again due to signs of infection.Batch review performed on (b)(6) 2017.Lot 144980: (b)(4) items manufactured and released on (b)(6) 2014.Expiration date: 2019-08-31.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 was revised due to signs of infection.The pathogen is unknown.The surgeon washed out the knee and swapped the poly.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED # 4 / 17 MM
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6921444
• Report Number: 3005180920-2017-00556
• Device Sequence Number: 10935678
• Product Code: JWH
• UDI-Device Identifier: 07630030817939
• UDI-Public: 07630030817939
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: 08/31/2019
• Device Catalogue Number: 02.07.0417FUC
• Device Lot Number: 144980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: 65 YR