FDA Adverse Event Injury Summary report: N

PLUS

MDR report key: 3143431 · Received June 3, 2013

Report

Report Number
9613369-2013-00045
Event Type
Injury
Date Received
June 3, 2013
Date of Event
June 28, 2011
Report Date
May 24, 2013
Manufacturer
SMITH & NEPHEW, INC.
Product Code
JDH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
244826 PLUS FEMORAL COMPONENT JDH SMITH & NEPHEW, INC.

Patients

Seq Age Sex Outcome Treatment
1 74 YR Hospitalization| R