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

Model Number PHA01204

Device Problem Insufficient Information (3190)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient is experiencing mom complications (right).The patient has scheduled to have the right hip implant explanted in (b)(6) 2014.Additional information received on 05/11/2023: allegedly, due to we received a new information about a revision surgery performed on 2023, we found an invoice of the revision surgery performed on 2014, a conserve a-class bfh head medium neck 40mm (38am4000) and profemur neck neutral long cobalt chrome (phac1204) were implanted, this means the head and neck implanted in the primary surgery were revised.The cup (product id: 38024854 conserve® plus cup, lot: 108676882, qty: 1) is unsure that was revised.

Manufacturer Narrative

Due to reliability findings, this device is not related to a deficiency.Please void the following report.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• 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: 17039111
• MDR Text Key: 316313606
• Report Number: 3010536692-2023-00101
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: 019772187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/20/2023
• 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: Female