FDA Adverse Event Injury Summary report: N

KNEE IMPLANT

MDR report key: 4200547 · Received October 24, 2014

Report

Report Number
1020279-2014-00664
Event Type
Injury
Date Received
October 24, 2014
Date of Event
October 21, 2014
Report Date
October 21, 2014
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC LOOSENING/OSTEOLYSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
678610 KNEE IMPLANT JWH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention