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

Model Number	PHA04412
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
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 dislocation/subluxation|periprosthetic fracture.Srnjr number: (b)(6).Side: l gender: f.
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 1-week after the primary operation due to alleged dislocation/instability and periprosthetic fracture.The provided information did not indicate if the fracture occurred to the acetabulum or femur.The revised products have not been returned to mpo for investigation, and mpo has not received radiographs, operative notes, or other clinically relevant information to confirm the alleged complications.Review of the device history record (dhr) for the subject manufacturing lots indicates that these products met all established acceptance criteria.Furthermore, mpo has not received any other complaint reports for the subject manufacturing lots.With the short time of occurrence after the index operation, it is possible that patient or surgical factors could have impacted the outcome of this patient.These complications are captured within the mpo hip systems package insert.Regarding dislocation, the package insert includes the following as a possible adverse effect of total hip arthroplasty: "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity." regarding periprosthetic fracture, it includes the following statement: "femoral or acetabular perforation or fracture; femoral fracture while seating the device; femoral fracture by trauma or excessive loading, particularly in the presence of poor bone stock." this package insert also notes, "the patient must be advised of the limitations of the reconstruction and the need for protection of the prosthesis from full weight bearing until adequate fixation and healing have occurred.The patient should be cautioned to limit activities and protect the replaced joint from unreasonable stresses and possible loosening, fracture and/or wear, and follow the instructions of the physician with respect to follow-up care and treatment." without additional information, mpo is unable to provide conclusions regarding this occurrence.There were no trends identified for these product families at the time of this complaint.Mpo will continue to monitor for these complications through complaint tracking.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L
• 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: 24176563
• Report Number: 3010536692-2026-00010
• Device Sequence Number: 10177981
• Product Code: LZO
• UDI-Device Identifier: M684PHA044121
• UDI-Public: M684PHA044121
• 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: 2025
• Device Explanted Year: 2025
• 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): 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: PHA04412
• Device Catalogue Number: PHA04412
• Device Lot Number: 2015600
• 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: 01/26/2026
• 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 Sex: Female