FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 3792508 · Received May 6, 2014

Report

Report Number
3005477969-2014-00300
Event Type
Injury
Date Received
May 6, 2014
Report Date
May 6, 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. IMPLANTATION WAS IN 2007.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
272381 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 54910

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization| R FEMORAL HEAD, # 74121142, LOT # 70774