MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® CEMENTLESS FC; HIP COMPONENT

Catalog Number 38PF-1052

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/19/2015

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Allegedly migration of prosthetic component from improper positioning.

• Brand Name: CONSERVE® A-CLASS® CEMENTLESS FC
• 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: 6795804
• MDR Text Key: 82750386
• Report Number: 3010536692-2017-01095
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38PF-1052
• Device Lot Number: 1450802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/26/2017
• Date Manufacturer Received: 07/26/2017
• 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 Age: 50 YR
• Patient Weight: 85