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

Model Number PHA01264

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 09/01/2022

Event Type  Injury  

Event Description

Allegedly, i have reviewed john today.Unfortunately he required revision of his right total hip replacement due to fracture of the modular neck.The broken off taper was unable to be removed and the femoral stem was revised to a smith and nephew redapt stem.The acetabulum was unchanged.On review today he is progressing well.He is no longer calling me david.He is walking with out aids for up to 100m and has managed to get buy in the caravan.He is waiting for his endurance to improve so that he can manage the trip back to victoria.I have not made any plans to review john but would be happy to do so if the need arises.The reporter sent that the surgeon told him that the revision was due to a fall.

Manufacturer Narrative

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

• 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: 16134053
• MDR Text Key: 307040268
• Report Number: 3010536692-2023-00006
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA01264
• Device Catalogue Number: PHA01264
• Device Lot Number: 1101224734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2022
• 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 Age: 75 YR
• Patient Sex: Male