MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® CEMENTLESS FEMORAL COMPONENT 48MM; HIP COMPONENT

Model Number 38PF1048

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/10/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to deep wound infection.Additional information : left side.

Manufacturer Narrative

Additional information received on (b)(6) 2020.Void this report , it is a duplicate of 3010536692-2018-00026.

• Brand Name: CONSERVE® CEMENTLESS FEMORAL COMPONENT 48MM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9659562
• MDR Text Key: 177402775
• Report Number: 3010536692-2020-00093
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M68438PF10481
• UDI-Public: M68438PF10481
• Combination Product (y/n): N
• PMA/PMN Number: K082673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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: 38PF1048
• Device Catalogue Number: 38PF1048
• Device Lot Number: 1453975
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 04/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 100