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

Model Number PPW38020

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

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 underwent a subsequent procedure on (b)(6) 2005 for greater trochanter fracture.

Manufacturer Narrative

Section b5: additional information in description / section d4: lot# added.

Event Description

Additional information received on 02,sep, 2021.Allegedly, a patient was underwent a subsequent procedure for greater trochanter fracture.

• 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: 12388543
• MDR Text Key: 268878185
• Report Number: 3010536692-2021-00462
• 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: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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: U1087562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Other