MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® RESURFACING FEMORAL HEAD 50MM; HIP COMPONENT

Model Number 38XXXX50

Device Problem Material Disintegration (1177)

Patient Problem Reaction (2414)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, in 2009 the patient developed left iliopsoas insufficiency and left hip flexion weakness.In 2018 there was evidence of fluid collection around the hip area, early tendon attrition, and urine cobalt levels of 12.4 mcg/l and blood cobalt levels of 2, 6 mcg/l.The patient also had evidence of neurologic affectation suggesting chronic toxic encephalopathy and adverse reaction to metallic debris.Upon revision it was found a cystic pseudotumor.

Manufacturer Narrative

Fda report number: mw5092199.

• Brand Name: CONSERVE® RESURFACING FEMORAL HEAD 50MM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9726784
• MDR Text Key: 182523705
• Report Number: 3010536692-2020-00140
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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: Other
• Device Model Number: 38XXXX50
• Device Catalogue Number: 38XXXX50
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 05/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention