MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

Catalog Number	02.07.0410FUC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2019: lot 120150: (b)(4) items manufactured and released on 28-mar-2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar event reported (mdr 2018-01069).Other device involved.Gmk-primary tibial insert uc fixed size 4 / 10 mm reference 02.07.0410fuc (k090988): lot 114247: (b)(4) items manufactured and released on 22-feb-2012.Expiration date: 2017-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
About 6 years and 2 months after primary the surgeon performed an i&d and liner swap on both knees for an infection.The surgery was completed successfully.The pathogen is unknown.

• Brand Name: GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
• Common Device Name: TIBIAL INSERT UC FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8252587
• Report Number: 3005180920-2018-01096
• Device Sequence Number: 1929288
• Product Code: JWH
• UDI-Device Identifier: 07630030817618
• UDI-Public: 07630030817618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 02/28/2017
• Device Catalogue Number: 02.07.0410FUC
• Device Lot Number: 120150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/16/2019
• 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