FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 1863668 · Received October 11, 2010

Report

Report Number
3005477969-2010-00175
Event Type
Injury
Date Received
October 11, 2010
Date of Event
June 17, 2010
Report Date
October 11, 2010
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 HEALTH CARE PROFESSIONAL

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
1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 33472 008

Patients

Seq Age Sex Outcome Treatment
1 51 YR Hospitalization| R FEMORAL HEAD, PART#121146, LOT# 32540 026