MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01204

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the femoral neck of the device suddenly failed, breaking into pieces.Additional information: left hip.

Manufacturer Narrative

Additional information was received on 10/29/2020: updated incident description and lot number.

Event Description

Allegedly, the femoral neck of the device suddenly failed, breaking into pieces.Additional information: left hip additional information provided on 10/29/2020 by (b)(4): product id and lot information.

Manufacturer Narrative

Added lot information that was not included on the previous report.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10043265
• MDR Text Key: 190530533
• Report Number: 3010536692-2020-00357
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: U1088875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2020
• Date Manufacturer Received: 04/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention