MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4; FEMORAL COMPONENT

Catalog Number	3010.004D
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by r&d project manager the femur component and the tibial plate haven't been cemented during primary surgery and this implants should be cemented.Batch review performed on 4 september 2019: lot 083036: (b)(4) items manufactured and released on 20-nov-2008.Expiration date: 31-10-2013.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.Other components were involved in the event evolis 3031.0003 ti plasma sprayed tibial baseplate size 3 lot 081768 (k081023): (b)(4) items manufactured and released on 28-nov-2008.Expiration date: 30-06-2013.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 performed after 9 years and 10 months from the primary due to instability which was caused by a loose tibial tray and femoral component.The surgeon revised the femoral component, tibial tray, and insert successfully.The primary implants were not cemented.

• Brand Name: EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9115067
• Report Number: 3005180920-2019-00795
• Device Sequence Number: 14107273
• Product Code: JWH
• UDI-Device Identifier: 07630030844522
• UDI-Public: 07630030844522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 3010.004D
• Device Lot Number: 083036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/25/2019
• 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