FDA Adverse Event Injury Summary report: N

BHR

MDR report key: 3230981 · Received July 17, 2013

Report

Report Number
3005477969-2013-00291
Event Type
Injury
Date Received
July 17, 2013
Date of Event
February 28, 2006
Report Date
July 17, 2013
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 PERIPROSTHETIC FRACTURE. THE ACETABULAR CUP REMAINED IMPLANTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
331778 BHR FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS LTD

Patients

Seq Age Sex Outcome Treatment
1 41 YR Hospitalization| R ACETABULAR CUP, PART # 120150, LOT # 7122 33