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

Model Number	PHA01252
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Discomfort (2330)
Date of Event	11/15/2022
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, troubleshooting situation: x-ray was taken due to the patient's complaint of discomfort, and it was found that the patient had dislocated.Next day, revision of neck, head, and bipolar cup replacement was performed.Physician's findings: the patient's fall caused a strong impact, and he suspected that the neck and bipolar cup were dislocated due to impingement.He also speculated that there is no doubt that there is also a wound on the implant that was removed.(b)(4).

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: 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: 16047653
• Report Number: 3010536692-2022-00446
• Device Sequence Number: 15039578
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012521
• UDI-Public: M684PHA012521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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
• Operator of Device: Other
• Device Model Number: PHA01252
• Device Catalogue Number: PHA01252
• Device Lot Number: 1892393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 03/13/2023
• 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 Sex: Unknown