MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) LX STEM

Model Number PRLX-0013

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/27/2018

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, patient revised due to cocr neck fracture.Right additional information received from legal, (b)(6) 2019.Patient had a broken stem.The stem and neck separated.Changing incident mode.Additional information received from wright medical legal, (b)(6) 2019.Adding corrosion and metal on metal complications.

• Brand Name: PROFEMUR(R) LX STEM
• Type of Device: STEM
• 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: 9156321
• MDR Text Key: 161800771
• Report Number: 3010536692-2019-01076
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PRLX-0013
• Device Catalogue Number: PRLX-0013
• Device Lot Number: 096351936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2019
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention