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

Model Number	PHA01254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, on (b)(6) 2005, patient underwent a total right hip replacement at (b)(6) hospital by a surgeon for progressive pain and dysfunction secondary to end-stage arthrosis of his right hip.On or about on (b)(6) 2022, while relaxing in a living room chair, patient had the sensation that something inside him broke and then felt excruciating pain in his right hip and radiating into his groin.Patient was transported to (b)(6) center, where x-rays revealed "a fracture of the femoral component.Patient remained hospitalized at (b)(6) until on (b)(6) 2022, when he was transported, via ambulance, to (b)(6) hospital where he underwent revision surgery on (b)(6) 2022, by surgeon.Surgeon findings: patient is now 17 years after index right total hip arthroplasty.He has had reasonably good function, but up until the last few months, he has had some symptoms, but really has maintained stability of the implant.On friday on (b)(6) 2022, he was getting up from a chair and felt a click in his hip and was unable to bear weight and he had immediate pain.He had really quite a lot of pain, limitation of his function since that time.History, physical examination, radiograph shows what appears to be a fracture of the implant at the top portion of his modular neck.This is also a bad suggestion because the patient has previously had surgery for trunnionosis on his contralateral side as a failure mechanism.Was discussed this with doctors being the index surgeon and we have elected that the best option would be revision of his right total hip arthroplasty.Because of the acetabulum only allows 32 mm bearings and not really terrific locking mechanism for a 32 mm plastic, was elected to revise his acetabulum as well.Were removed the broken femoral neck and the head.Were removed any and all complete capsulectomy.Products implanted during revision surgery (other legal manufacturer): stem, neck, shell, insert, screw, head.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: 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: 18841671
• Report Number: 3010536692-2024-00124
• Device Sequence Number: 20697339
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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
• Operator of Device: Other
• Device Model Number: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: U12118234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male