MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM PLASMA SPRAYED; HIP COMPONENT

Model Number	PHA00262
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent a left total hip arthroplasty on (b)(6) 2017 at (b)(6) (california).She was implanted with the profemur® total hip system, consisting of a profemur z titanium stem and a short cobalt-chromium modular neck.Over time, the device began to fail at the neck stem junction, leading to corrosion and the release of metallic debris.This caused the patient to experience progressive hip pain, prosthesis instability, formation of a pseudotumor, and metallosis (accumulation of metallic particles in the surrounding tissue).On (b)(6) 2025, the patient underwent a revision surgery at (b)(6) (california).During this procedure, both the stem and the modular neck of the profemur® system were explanted, due to corrosion and related tissue damage.Pathology confirmed chronically inflamed fibrotic tissue with entrapped bone particles and metallic debris, along with visible black corrosion at the neck stem junction, establishing that the failure was caused by corrosion of the cobalt-chromium modular neck coupled with the titanium stem.Patient underwent a left total hip arthroplasty on (b(6_ 2017 at (b)(6) hospital (california).She was implanted with the profemur® total hip system, consisting of a profemur z titanium stem and a short cobalt-chromium modular neck.Over time, the device began to fail at the neck stem junction, leading to corrosion and the release of metallic debris.This caused the patient to experience progressive hip pain, prosthesis instability, formation of a pseudotumor, and metallosis (accumulation of metallic particles in the surrounding tissue).On (b)(6) 2025, the patient underwent a revision surgery at (b)(6) (california).During this procedure, both the stem and the modular neck of the profemur® system were explanted, due to corrosion and related tissue damage.
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.Based on the information provided, this female patient was revised approximately 87 months after the index operation due to alleged adverse tissue reaction associated with corrosion of the cocr modular neck and titanium-alloy modular femoral stem.There are not any patient specific details available such as age, height, weight, or activity level.A review of the invoice for the index surgery does not include mpo acetabular implants, which suggests the possibility that the implanting surgeon combined mpo femoral implant with acetabular implants from a different manufacturer.The explanted devices have not been returned to mpo for evaluation.Additionally, mpo was not provided with radiographs, images, operative notes, or other clinical information to substantiate the alleged complaint against the mpo devices.Review of the device history record (dhr) for the subject manufacturing lots indicates that these devices met all established acceptance criteria throughout manufacturing processes.Furthermore, mpo has not received any other complaint reports involving the subject manufacturing lots.The potential for adverse reaction to a cocr modular neck is an issue addressed by corrective and preventive action (capa) #282.This capa determined the following: "the potential for a patient reaction when implanted with a profemur® cocr modular neck is a known risk for this product technology.A combination of patient and surgical factors can contribute to an elevated risk of an adverse patient reaction.These factors include, but are not limited to, patient sensitivity, surgical technique, patient weight and activity level." additionally, the microport hip systems package insert (150803-9) lists "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as possible adverse effects associated with total hip arthroplasty.No conclusions regarding potential product contribution to the alleged complications can be determined from the available information.There were not any trends identified for this device and complaint type at the time of this complaint.Mpo will continue to monitor this complaint through complaint tracking.

• Brand Name: PROFEMUR® Z STEM PLASMA SPRAYED
• 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: 23325793
• Report Number: 3010536692-2025-00351
• Device Sequence Number: 14986939
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/12/2025

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: PHA00262
• Device Catalogue Number: PHA00262
• Device Lot Number: 15203981561311
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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: Female