FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 4192497 · Received October 22, 2014

Report

Report Number
3005477969-2014-00541
Event Type
Injury
Date Received
October 22, 2014
Date of Event
September 24, 2014
Report Date
October 22, 2014
Manufacturer
SMITH & NEPHEW
Product Code
NXT
PMA / PMN Number
P040033
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
672223 BHR ACETABULAR CUP NXT SMITH & NEPHEW

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R FEMORAL HEAD, PART AND LOT # UNKNOWN