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

Catalog Number 3803-1048

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2013

Event Type  Injury  

Event Description

Allegedly the patient was revised due to other indications (left).

Manufacturer Narrative

Investigation is not complete.Trends will be evaluated.This is the same event as 3010536692-2014-00273.This report will be updated when the investigation is complete.This event occurred in (b)(6).

• Brand Name: CONSERVE(R) SUPER FINISH FEMORAL
• Type of Device: HIP COMPONENT, CODE:KXA
• 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 ; 901867-441
• MDR Report Key: 3639052
• MDR Text Key: 4181505
• Report Number: 3010536692-2014-00274
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 3803-1048
• Device Lot Number: 115286919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/12/2013
• Event Location: Hospital
• Date Manufacturer Received: 04/02/2014
• 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