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

Model Number PHA0-1252

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trend will be evaluated.

Event Description

Allegedly the patient was revised due to what seems to be taper wear.

Manufacturer Narrative

Updated device information, event and evaluation codes.Updated implant date.

• 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: 7885021
• MDR Text Key: 120541036
• Report Number: 3010536692-2018-01211
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: PHA0-1252
• Device Catalogue Number: PHA0-1252
• Device Lot Number: T10132743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/07/2018
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 05/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention