FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 3251505 · Received July 29, 2013

Report

Report Number
3005477969-2013-00317
Event Type
Injury
Date Received
July 29, 2013
Report Date
March 26, 2014
Manufacturer
SMITH & NEPHEW ORTHOPAEDICS LTD
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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
352399 BHR ACETLR CUP HAP 50MM W/ IMPTR NXT SMITH & NEPHEW ORTHOPAEDICS LTD 1553

Patients

Seq Age Sex Outcome Treatment
1 54 YR Hospitalization| R 74121142 - RESUR FEM HD 42MM -5737 40| FEMORAL HEAD, PART AND LOT# UNKNOWN