MalfunctionLZO

2.5 I M PLUG

Received Jul 6, 2026

Report MW5190228 · MDR key 25715687

Device

Generic name

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Manufacturer

Howmedica Osteonics Corp.

Model number

09390110

Product problems

Patient Device Interaction Problem

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

EVENT DESCRIPTION: IT WAS REPORTED THAT THE HIP REVISION PROCEDURE IS BEING UNDERTAKEN DUE TO A LOOSE FEMORAL STEM RELATED TO THE CEMENT MANTLE. THE SURGEON PLANS TO RETAIN THE EXISTING PINNACLE ACETABULAR SHELL, REMOVE THE INTACT CERAMIC LINER, AND REPLACE IT WITH A PINNACLE DM LINER TO IMPROVE STABILITY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). PT: 4582. DEVICE: 4001. REF: MW5190227, MW5190229, MW5190230. THIS REPORT CAPTURES 2.5 I M PLUG #2.