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

Catalog Number 3802-1048

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Foreign Body Reaction (1868); Hyperplasia (1906); Pain (1994); Synovitis (2094); Chemical Exposure (2570); Foreign Body In Patient (2687); Test Result (2695); No Code Available (3191)

Event Date 03/13/2014

Event Type  Injury  

Event Description

Allegedly suffering due to mom complications: pain,elevated cobalt levels, effusions, hypertrophic overgrowth, synovitis, hyperplasia, pigment deposition, and foreign material.Right.

Manufacturer Narrative

This is the same event as 3010536692-2015-01212.

• Brand Name: CONSERVE(R) PLUS SUPER FINISH FEMORAL
• 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 ; 901867-477
• MDR Report Key: 4803650
• MDR Text Key: 5929602
• Report Number: 3010536692-2015-01213
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 3802-1048
• Device Lot Number: 05487215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR