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

Model Number PHA0-1252

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revised due to pain.

Manufacturer Narrative

Additional information received on 05/08/2019 that adds patient and/or device codes.

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 7451110
• MDR Text Key: 106180495
• Report Number: 3010536692-2018-00458
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K003016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

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: 1558800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2018
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/13/2018; 04/13/2018
• Supplement Dates FDA Received: 10/04/2019; 02/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention