FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 2240632 · Received September 9, 2011

Report

Report Number
3005477969-2011-00223
Event Type
Injury
Date Received
September 9, 2011
Report Date
September 9, 2011
Manufacturer
SMITH & NEPHEW ORTHOPAEDICS LTD
Product Code
NXT
PMA / PMN Number
P040033
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
SZ
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED TO EXCHANGE THE FEMORAL COMPONENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BHR FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS LTD

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R