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

Model Number	PHA04404
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, after the initial surgery on (b)(6), the patient underwent rehabilitation including gait training, but complained of pain and had difficulty walking, so an x-ray confirmed dislocation.The patient was able to manually repair the dislocation, but later dislocated again, so a revision operation was performed to replace the neck, head, and bipolar cup, and the patient has been stable since then.Doctor's finding: the patient had undergone rehabilitation after the initial operation, but repeated dislocations occurred, so a revision operation was performed.We would like to request an investigation to see if the dislocation could have been caused by the product.Japan-oc00000588.
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 M
• 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: 21242729
• Report Number: 3010536692-2025-00020
• Device Sequence Number: 12887941
• Product Code: LZO
• UDI-Device Identifier: M684PHA044041
• UDI-Public: M684PHA044041
• 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: 2024
• 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): 11/19/2025

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: PHA04404
• Device Catalogue Number: PHA04404
• Device Lot Number: 1993591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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 Sex: Unknown