MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01252

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Discomfort (2330)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, troubleshooting situation: x-ray was taken due to the patient's complaint of discomfort, and it was found that the patient had dislocated.Next day, revision of neck, head, and bipolar cup replacement was performed.Physician's findings: the patient's fall caused a strong impact, and he suspected that the neck and bipolar cup were dislocated due to impingement.He also speculated that there is no doubt that there is also a wound on the implant that was removed.(b)(4).

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 16047653
• MDR Text Key: 306156937
• Report Number: 3010536692-2022-00446
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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: Other
• Device Model Number: PHA01252
• Device Catalogue Number: PHA01252
• Device Lot Number: 1892393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2022
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/26/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 03/13/2023
• 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