MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD; HIP COMPONENT

Model Number 38AM-4800

Device Problem Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Date 05/30/2019

Event Type  Injury  

Event Description

Allegedly, subjects blood was drawn and mri was taken at study visit per protocol.The radiologist at our who read the mri results suggested an altr.Our pi confirmed this based on the mri and the subject's blood testing results.Our pi is planning to offer the subject a revision surgery.Subject will be contacted by orthopedics clinic to set up the appointment to discuss revision.

Manufacturer Narrative

Device explanted on (b)(6) 2019.

• Brand Name: CONSERVE A-CLASS BFH HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11016239
• MDR Text Key: 221731608
• Report Number: 3010536692-2020-00774
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38AM-4800
• Device Catalogue Number: 38AM-4800
• Device Lot Number: 068648142
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 109