MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. MICROPORT PROFEMUR RENAISSANCE FEMORAL STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Patient Problems Fall (1848); Failure of Implant (1924); Hip Fracture (2349)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Patient seen in er (emergency room) for hip pain.Found to have a periprosthetic right hip fracture post fall.Catastrophic failure of the femoral stem at the modular neck junction.Device implement 10 years ago.Patient had a right total hip arthroscopy revision multicomponent on (b)(6) 2024.

• Brand Name: MICROPORT PROFEMUR RENAISSANCE FEMORAL STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; arlington TN 38002
• MDR Report Key: 18799535
• MDR Text Key: 336565335
• Report Number: MW5152099
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White