InjuryLWJ

PROFEMUR® MODULAR FEMORAL NECK

Received Aug 14, 2024 · Event occurred Jul 12, 2023

Report 3010536692-2024-00424 · MDR key 19984230

Device

Generic name

Hip Component

Manufacturer

Microport Orthopedics Inc.

Model number

PHA01204

Catalog number

PHA01204

Lot number

117507949

Product problems

Break
Break

Patient

NA · Male

Pain
Pain

Narrative

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, THE PROFEMUR MODULAR NECK IN THE PATIENT'S LEFT HIP SUDDENLY AND WITHOUT WARNING FAILED, FRACTURED, BREAKING INTO TWO PIECES. AT THE TIME OF THE FRACTURE, THE PATIENT WAS WALKING AROUND HIS HOME, IN AT THE TIME OF THE FRACTURE, THE PATIENT WAS PAIN AND UNABLE TO WALK.