FDA Adverse Event Injury Summary report: N

EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4

MDR report key: 9115067 · Received September 25, 2019

Report

Report Number: 3005180920-2019-00795
Event Type: Injury
Date Received: September 25, 2019
Date of Event: August 26, 2019
Report Date: September 25, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030844522
PMA / PMN Number: K081023
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
915040	EVOLIS STD FEMUR TI PLASMA SPRAYED RIGHT SIZE 4	FEMORAL COMPONENT	JWH	MEDACTA INTERNATIONAL SA		083036	07630030844522

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention