inforMED
MalfunctionLZO

CERAMIC V40 FEMORAL HOSPITAL

Received Jul 6, 2026

Report MW5190227 · MDR key 25715682

Device

Generic name

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous

Model number

65700032

Lot number

99388001

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. REFERENCE REPORTS: MW5190228, MW5190229, MW5190230. THIS REPORT CAPTURES CERAMIC V40 FEMORAL HEAD #1.