FDA Adverse Event Injury Summary report: N

PROFEMUR(R) MODULAR FEMORAL NECK

MDR report key: 4111364 · Received September 23, 2014

Report

Report Number
3010536692-2014-01408
Event Type
Injury
Date Received
September 23, 2014
Date of Event
September 1, 2014
Report Date
September 1, 2014
Manufacturer
MICROPORT ORTHOPEDICS INC.
Product Code
LWJ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
AU
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION IS NOT COMPLETE; REPORT WILL BE UPDATED WHEN COMPLETE. TRENDS WILL BE EVALUATED. THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

ALLEGEDLY THE PT. STUMBLED OVER A SILL AND FELL ON LEFT HIP, BREAKING NECK COMPONENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
589881 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. W1037279

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention