MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) FEMORAL COMPONENT; HIP COMPONENT

Model Number 38PF-1054

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 09/07/2016

Event Type  Injury  

Event Description

Allegedly, subject was experiencing pain post- l hip resurfacing.Pseudotumor was discovered on (b)(6) 2016 and subject was scheduled for revision surgery.Subject was revised to a total hip device on (b)(6) 2017.

• Brand Name: CONSERVE(R) FEMORAL COMPONENT
• 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: 7957767
• MDR Text Key: 123436964
• Report Number: 3010536692-2018-01250
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

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: Health Professional
• Device Model Number: 38PF-1054
• Device Catalogue Number: 38PF-1054
• Device Lot Number: 1441015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2018
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/11/2018
• 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
• Patient Weight: 87