MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0314PSF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-nov-2019: lot 140222: 30 items manufactured and released on 08-apr-2014.Expiration date: 28/02/2019.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any other similar reported event.Additional device involved: batch review performed on 11-nov-2019: gmk-primary 02.07.0317psf tibial insert ps fixed size 3/17mm (k090988) lot 114227: 30 items manufactured and released on 19-feb-2012.Expiration date: 31-dec-2016.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of infection 4 years and 5 months after the primary, the pathogen is unknown.The surgeon performed a washout and poly-swap on the patient's left and right knee and the surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9393610
• Report Number: 3005180920-2019-00999
• Device Sequence Number: 18927882
• Product Code: JWH
• UDI-Device Identifier: 07630030817267
• UDI-Public: 07630030817267
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 02/28/2019
• Device Catalogue Number: 02.07.0314PSF
• Device Lot Number: 140222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/02/2019
• 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