MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1254

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Allegedly, we inform you that the medical expert opinion requested by the cci on the patient will take place on friday, november 17 at 2:30 p.M.At the office of dr in 21 boulevard debrosses 21000 dijon.The expertise concerns patient for a fracture on a modular neck.This expertise is contradictory, all parties are summoned.The wrigth type prostheses, xstem gladiator, modular neck, installed in 2015 at the nancy university hospital.

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18149695
• MDR Text Key: 328294967
• Report Number: 3010536692-2023-00208
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12541
• UDI-Public: M684PHAC12541
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: 1583571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male