MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® ROUGHENED DISTAL STEM, TAPERED; HIP COMPONENT

Model Number PPW38020

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, a patient was revised for stem fracture.Components not revised: unknown cup, unknown part id.

Manufacturer Narrative

Section: d.4: lot number added.

• Brand Name: PROFEMUR® ROUGHENED DISTAL STEM, TAPERED
• 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: 12430945
• MDR Text Key: 270062043
• Report Number: 3010536692-2021-00498
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PPW380201
• UDI-Public: M684PPW380201
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PPW38020
• Device Catalogue Number: PPW38020
• Device Lot Number: T07125245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/12/2021
• Date Manufacturer Received: 08/12/2021
• 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