FDA Adverse Event Injury Summary report: N

UNIVERSAL

MDR report key: 2121313 · Received June 13, 2011

Report

Report Number
1020279-2011-00197
Event Type
Injury
Date Received
June 13, 2011
Date of Event
May 25, 2011
Report Date
June 13, 2011
Manufacturer
SMITH & NEPHEW, ORTHOPEDICS
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 DUE TO LOOSENING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 UNIVERSAL FEMORAL HEAD JDH SMITH & NEPHEW, ORTHOPEDICS

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention