MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 2 L; KNEE FEMORAL COMPONENT

Catalog Number	02.07.2402L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 160307: (b)(4) items manufactured and released on 24-mar-2016.Expiration date: 2021-03-03.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.Additional components involved: gmk-revision 02.07.0681l revision fixed tibial tray cemented size 1 l (k123721), lot 155877: (b)(4) items manufactured and released on 15-jan-2016.Expiration date: 2020-12-19.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-revision 02.07.0110scf fixed tibial insert sc size 1/10mm (k103170), lot 155555: (b)(4) items manufactured and released on 21-sep-2015.Expiration date: 2020-08-04.No anomalies found related to the problem.To date, no other item of the same lot have been already sold.
Event or Problem Description
The patient came in, 2 years and 4 months after primary surgery, due to signs of infection.The surgeon explanted all implants, performed a washout and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 2 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8473645
• Report Number: 3005180920-2019-00240
• Device Sequence Number: 1846288
• Product Code: JWH
• UDI-Device Identifier: 07630030821387
• UDI-Public: 07630030821387
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/02/2019

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: 03/03/2021
• Device Catalogue Number: 02.07.2402L
• Device Lot Number: 160307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/02/2019
• 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