MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR RENAISSANCE MODULAR STEM; HIP COMPONENT

Model Number PLS0X41X

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Allegedly, patient seen in er for hip pain.Found to have a periprosthetic right hip fractured 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.

Manufacturer Narrative

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

• Brand Name: PROFEMUR RENAISSANCE MODULAR STEM
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18895359
• MDR Text Key: 337562406
• Report Number: 3010536692-2024-00135
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLS0X41X
• Device Catalogue Number: PLS0X41X
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male