InjuryLWJ

PROFEMUR® MODULAR FEMORAL NECK

Received Jun 21, 2024

Report 3010536692-2024-00361 · MDR key 19586538

Device

Generic name

Hip Component

Manufacturer

Microport Orthopedics Inc.

Model number

PHA01212

Catalog number

PHA01212

Lot number

W09896761

Product problems

Break
Break

Patient

63 YR · Female

Insufficient Information
Insufficient Information

Narrative

Additional Manufacturer Narrative

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

Description of Event or Problem

ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE OF A NON CERAMIC COMPONENT - STEM/PERIPROSTHETIC FRACTURE. SRNJR NUMBER: 5420811. SIDE: L. GENDER: F. NON MPO PRODUCTS: PRODUCT ID: 588542262 DELTA LINER ØINT 40MM # LARGE. BIOLOX ® DELTA/ LOT NO: UNKNOWN/ QTY: 1. PRODUCT ID: 555215540 DELTA-TT ACETAB.CUP Ø54MM. FOR LINERS SIZE LARGE TI6AL4V/ LOT NO: UNKNOWN/ QTY: 1. MPO CERAMIC PRODUCTS: PRODUCT ID: PHA04422 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 M/ LOT NO: 5113615691/ QTY: 1.