FDA Adverse Event Injury Summary report: N

PROFEMUR MODULAR FEMORAL NECK

MDR report key: 9756699 · Received February 26, 2020

Report

Report Number
3010536692-2020-00150
Event Type
Injury
Date Received
February 26, 2020
Date of Event
January 18, 2020
Report Date
June 9, 2020
Manufacturer
MICROPORT ORTHOPEDICS INC.
Product Code
LWJ
UDI-DI
M684PHA012121
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
ES
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

ALLEGEDLY, THE PATIENT WENT TO EMERGENCY DUE TO A HIP DISLOCATION. THE X RAYS SHOWED THE FRACTURE NECK. AEMPS: PS/MRG/58073.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
221045 PROFEMUR MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. PHA01212 1579913 M684PHA012121

Patients

Seq Age Sex Outcome Treatment
1 63 YR Required Intervention