MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR®XM DISTAL CENTRALIZER; HIP COMPONENT

Model Number	PRXMDC01
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
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.Srnjr number: (b)(6).Side: r.Gender: f.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint does not reveal any failure involving this implant.Mpo was made aware of this incident through the united kingdom national joint registry.The revised products were not returned, and no explant images, radiographs, operative notes, or other clinically relevant documentation is available for review to confirm this occurrence.This implant was implanted in a 80 yo female patient for approximately 1 month before revision due to dislocation was required.These lots were manufactured in 2020 (pha04408), 2022 (pha060e0), and 2024 (ppec0l32, ppamq048, prxmdc01).Review of the design history record (dhr) for the subject manufacturing lots indicate that these implants were manufactured to specification.There are no trends for these implants and failure.Dislocation is one of the most common complications of total hip arthroplasty and can be influenced by both patient and/or surgical factors such as implant choice, technique, implant alignment, and tissue laxity.The microport hip systems package insert (150803-9) lists ?dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity? as a potential adverse effect of total hip arthroplasty.Without additional details, no conclusions can be drawn.Mpo will continue to monitor for complaint trends.Methods: analysis of production records (3331).Device not returned (4114).Trend analysis (4110).Results: no findings available (3221).Conclusions: device met specification.Device was used for treatment.Known inherent risk of device (22).Cause not established (4315).Correct type of reportable event: serious injury.

• Brand Name: PROFEMUR®XM DISTAL CENTRALIZER
• 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: 21209903
• Report Number: 3010536692-2025-00010
• Device Sequence Number: 3943192
• Product Code: LPH
• UDI-Device Identifier: M684PRXMDC011
• UDI-Public: M684PRXMDC011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052915
• 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,Followup
• Report Date (Section B): 11/26/2025

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: PRXMDC01
• Device Catalogue Number: PRXMDC01
• Device Lot Number: 2024928
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 10/30/2025; 11/26/2025
• 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: 80 YR
• Patient Sex: Female