MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT

Model Number	PHA04416
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
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, patient was revised due to infection.Srnjr number: (b)(6).Side: l.Gender: m.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Mpo was made aware of this revision from registry data.The patient underwent a revision operations approximately 14 months after the primary operation due to alleged infection.The revised products have not been returned to mpo for investigation, and mpo has not received operative notes or other clinically relevant information to confirm the alleged infection.Review of the device history record (dhr) for the subject manufacturing lots indicates that these products met all established acceptance criteria, including all aspects associated with cleaning, packaging, and sterilization.Furthermore, there were no trends identified for the subject manufacturing lots.These complications are captured within the mpo hip systems package insertmincludes the following as a possible adverse effect of total hip arthroplasty: "deep wound infection (early or late) which may necessitate removal of the prosthesis." without additional information, mpo is unable to provide conclusions regarding the possible source of the infection.There were no trends identified for these product families at the time of this complaint.Mpo will continue to monitor for complain trends.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 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: 24200261
• Report Number: 3010536692-2026-00012
• Device Sequence Number: 9672081
• Product Code: LZO
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 02/20/2026

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: Other
• Device Model Number: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 2012265
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male