FDA Adverse Event Injury Summary report: N

PROFIX CEMENTED TIBI

MDR report key: 2822460 · Received November 7, 2012

Report

Report Number
1020279-2012-00602
Event Type
Injury
Date Received
November 7, 2012
Date of Event
November 6, 2012
Report Date
November 6, 2012
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 WAS PERFORMED DUE TO PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PROFIX CEMENTED TIBI PRO NON-POR TB BASE RT S3 JWH SMITH & NEPHEW, INC. 03FM05685

Patients

Seq Age Sex Outcome Treatment
1 62 YR Required Intervention (B)(4)