FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 3920991 · Received July 9, 2014

Report

Report Number
3005477969-2014-00383
Event Type
Injury
Date Received
July 9, 2014
Date of Event
January 3, 2014
Report Date
July 8, 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 DUE TO PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
401355 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 53661

Patients

Seq Age Sex Outcome Treatment
1 44 YR Hospitalization| R MODULAR HEAD, PART #74121246, LOT #52031