MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R VAR/VAL 1 LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1224
Medical Device Problem Codes	Break (1069); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2024
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) 2024, the patient was standing in his living room and bent over to pick up a phone charger when he felt a sudden pop in his right hip and immediately fell to the floor.He experienced pain and was unable to bear weight on his right leg.X-rays revealed an angulated fracture of the femoral component of his right hip arthroplasty hardware, later confirmed as a fractured modular neck stem, which necessitated revision surgery performed on (b)(6) 2024.Non-revised products: product id: dsbfgg58 dynasty® bf shell 58mm group g/ lot no.: 1512229/ qty: (b)(4).Product id: 18080304 cancellous self-tapping 6.5mm bone screw 3.5cm length/ lot no.: 1462885/ qty: (b)(4).

• Brand Name: PROFEMUR® NECK A/R VAR/VAL 1 LONG COBALT CHROME
• 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: 24841247
• Report Number: 3010536692-2026-00073
• Device Sequence Number: 15724682
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12241
• UDI-Public: M684PHAC12241
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 04/10/2026

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: Health Professional
• Device Model Number: PHAC1224
• Device Catalogue Number: PHAC1224
• Device Lot Number: 0711382765
• 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: 03/23/2026
• Initial Report FDA Received Date: 04/10/2026
• 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