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

Catalog Number 3803-1044

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Host-Tissue Reaction (1297)

Event Date 07/24/2014

Event Type  Injury  

Event Description

Allegedly the patient was revised due to adverse soft tissue reaction to particle debris (left).(b)(6).

Manufacturer Narrative

This is the same event as 3010536692-2014-01588.This event occurred in (b)(6).

• Brand Name: CONSERVE(R) 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 ; 901867-441
• MDR Report Key: 4241823
• MDR Text Key: 4986226
• Report Number: 3010536692-2014-01589
• 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
• Report Date: 10/15/2014

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: Physician
• Device Catalogue Number: 3803-1044
• Device Lot Number: 0949164710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/24/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/10/2014
• 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