MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE PLUS 52MM FEMORAL HEAD; HIP COMPONENT

Model Number 38XXXXXX

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

Patient Problems Unspecified Infection (1930); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the modular neck was removed.Additional information received on 03/04/2021 from distributor: additional incident description, product names, revision date, approximate year of implantation, facility of revision, confirmation that all products were revised and indication of inability to provide product id's and lot numbers.Allegedly, patient revised due to a possible pseudotumor and possible infection.Implants gone to microbiology lab for testing.

Manufacturer Narrative

See investigation attached.

• Brand Name: CONSERVE PLUS 52MM FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11563345
• MDR Text Key: 242057922
• Report Number: 3010536692-2021-00173
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38XXXXXX
• Device Catalogue Number: 38XXXXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2021
• Date Manufacturer Received: 03/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR