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

Model Number PHA012XX

Device Problems Mechanical Problem (1384); Naturally Worn (2988)

Patient Problem Loss of Range of Motion (2032)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, dr.(b)(6) performed a revision on a modular neck/profemur z from 15 years ago.The cup had spun out and the neck was pushed proximally.When dr.(b)(6) removed the head, the trunyon of the modular neck had been eroded down to basically a sharp point.After attempting multiple approaches to remove the neck with no success, dr.(b)(6) performed an eto to remove the entire profemur z (size 8) stem.He implanted a new zimmer cup and stem.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 11958938
• MDR Text Key: 254884487
• Report Number: 3010536692-2021-00323
• Device Sequence Number: 1
• Product Code: LWJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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: PHA012XX
• Device Catalogue Number: PHA012XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2021
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 02/16/2022
• 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 Sex: Male