MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M; HIP COMPONENT

Model Number	PHA04410
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent thr on (b)(6) 2019.Revised on (b)(6) 2024 due to an infection.Washout performed, head and liner replaced.Australia-c24-597.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.This 67-year-old female patient was revised approximately 67 months after the primary operation.During the revision, the ceramic femoral head and polyethylene acetabular liner were removed and replaced.Review of the device history record (dhr) for the subject manufacturing lots indicates that this product met all established acceptance criteria throughout manufacturing processes, including all aspects related to cleaning and sterility.Additionally, mpo has not received any other reports for the subject manufacturing lots, nor for any manufacturing lots processed in the same sterile batches as these lots.Infection is a known risk of any surgical procedure.The current microport hip systems package insert (150803-9) lists "delayed wound healing; deep wound infection (early or late) which may necessitate removal of the prosthesis" as potential adverse effects of total hip arthroplasty.It cannot be concluded what the level of contribution, if any, that the product had to the complaint.There were no trends identified for these products per mpo trending procedures no further evaluations can be made without return of the products or receipt of other clinical information.This issue will continue to be monitored through complaint tracking.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 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: 21023264
• Report Number: 3010536692-2024-00507
• Device Sequence Number: 18228387
• Product Code: LZO
• UDI-Device Identifier: M684PHA044101
• UDI-Public: M684PHA044101
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: PHA04410
• Device Catalogue Number: PHA04410
• Device Lot Number: 1789282
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 12/08/2025
• 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: 67 YR
• Patient Sex: Female