MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 6 / 12 MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0612SF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018: lot 150799: (b)(4) items manufactured and released on 03 june 2015.Expiration date: 2020-04-30 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.Gmk-primary tibial insert std fixed # 5 / 12 mm reference 02.07.0512sf (k090988): lot 152600: (b)(4) items manufactured and released on 10 november 2015.Expiration date: 2020-10-20.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
Revision surgery due to signs of infection 1 month and half after the primary surgery on the right knee, 1 year and 4 months after the primary surgery on the left knee.The pathogen is unknown.The surgeon swapped the poly in both knees.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 6 / 12 MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7706378
• Report Number: 3005180920-2018-00526
• Device Sequence Number: 600644
• Product Code: JWH
• UDI-Device Identifier: 07630030818929
• UDI-Public: 07630030818929
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 04/30/2020
• Device Catalogue Number: 02.07.0612SF
• Device Lot Number: 150799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/20/2018
• 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