MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® PRESERVE STEM SIZE 6 HIP COMPONENT

Model Number PRPR0006

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly breakage of straight femoral stem.

• Brand Name: PROFEMUR® PRESERVE STEM SIZE 6
• 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: 8928692
• Report Number: 3010536692-2019-01019
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PRPR00061
• UDI-Public: M684PRPR00061
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112080
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PRPR0006
• Device Catalogue Number: PRPR0006
• Device Lot Number: 1406153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2019
• Event Location: No Information
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 68 YR
• Patient Outcome(s): Required Intervention