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

Model Number 38PF1048

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, xray showed a fractured at the femoral neck of his right side , just below the level of prosthesis.A visit with dr (b)(6) on (b)(6) 2019 indicated the stress fractured was healed , and subject was gradually returning to regular activities.Subject was treated non-operatively and received tylenol and tramadol while in the emergency department.

Manufacturer Narrative

Investigation completed.Evaluation codes added.

• 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: 10320084
• MDR Text Key: 200225047
• Report Number: 3010536692-2020-00500
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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: 1675586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 72