MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S; HIP COMPONENT

Model Number	PHA04402
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the artificial head was dislocated, and the bipolar cup was dislocated during manual healing.An emergency contemplative surgery was performed and the cup was replaced with a tha with dual mobility.Physician's findings: the dislocation led to a surgery that was very burdensome to the patient.The patient was asked to investigate the cause and report back.Findings of the reporter and status of response: the ring of the bipolar cup is fixed, and it is a puzzling case as to how the prolapse occurred.Only cup and head return.Related mpo products: product id: prtls027 profemur® tl classic stem size 7 straight short neck/ lot no.: 1802476/ qty: 1.(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S
• 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: 20907183
• Report Number: 3010536692-2024-00494
• Device Sequence Number: 17161416
• Product Code: LZO
• UDI-Device Identifier: M684PHA044021
• UDI-Public: M684PHA044021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/08/2025

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: PHA04402
• Device Catalogue Number: PHA04402
• Device Lot Number: 1920046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male