inforMED
MalfunctionLXH

HIP INSTRUMENTS

Received Jul 15, 2026 · Event occurred Jul 3, 2026

Report 3005180920-2026-00729 · MDR key 25822782

Device

Generic name

Proximal Body Handle

Model number

01.22.10.0151

Lot number

2481698

Product problems

  • Material Deformation
  • Mechanical Jam

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING A REVISION SURGERY PERFORMED APPROXIMATELY ONE MONTH AFTER THE PRIMARY PROCEDURE TO ADJUST THE BODY LENGTH (3005180920-2026-00721), SIGNIFICANT FORCE WAS REQUIRED WHEN ATTEMPTING TO DISCONNECT THE PROXIMAL BODY FROM THE DISTAL STEM, RESULTING IN DEFORMATION OF THE INSTRUMENTS. THE BODY COULD NOT BE DISENGAGED, AND THEREFORE THE ENTIRE STEM HAD TO BE EXPLANTED.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 06 JUL 2026 LOT 2481698: (b)(4) MANUFACTURED AND RELEASED ON 26-AUG-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. LOT 2358198: (b)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, TWO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW.