MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

Catalog Number	02.07.0310PSF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Primary surgery left knee - (b)(6) 2015.Primary surgery right knee - (b)(6) 2013.Batch review performed on 15 march 2018; lot 124608: (b)(4) items manufactured and released on 07 february 2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event gmk-primary tibial insert ps fixed size 2/12mm reference 02.07.0212psf (k090988); lot 130899: (b)(4) items manufactured and released on 24 april 2013.Expiration date: 2018-03-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of infection in both knees.The pathogen is unknown.The surgeon performed an i & d and swapped the poly on both sides.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM
• Common Device Name: TIBIAL INSERT PS FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7344704
• Report Number: 3005180920-2018-00155
• Device Sequence Number: 36016
• Product Code: JWH
• UDI-Device Identifier: 07630030817069
• UDI-Public: 07630030817069
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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: 12/31/2017
• Device Catalogue Number: 02.07.0310PSF
• Device Lot Number: 124608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/16/2018
• 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
• Patient Age: 70 YR