HIP INSTRUMENTS
Received Jul 8, 2026 · Event occurred Jun 8, 2026
Report 3005180920-2026-00642 · MDR key 25744804
Device
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 TO REALIGN THE PROXIMAL BODY, THE SURGEON WAS UNABLE TO DISENGAGE THE PROXIMAL COMPONENT. AS A RESULT, THE ENTIRE M-VIZION STEM HAD TO BE EXPLANTED. ACCORDING TO HIS ASSESSMENT, THE DISASSEMBLY ROD WAS BENT, PREVENTING THE SEPARATION OF THE M-VIZION COMPONENTS. THE SURGICAL PROCEDURE WAS PROLONGED BY 30 MIN OVER A 2-HOUR SURGERY BECAUSE THE DISTAL COMPONENT ALSO HAD TO BE EXPLANTED, ALTHOUGH THIS HAD NOT BEEN PLANNED INITIALLY.
Additional Manufacturer Narrative
BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO DETAILED INVESTIGATION COULD BE COMPLETED. WE ARE CURRENTLY ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION TO ENABLE A MORE COMPREHENSIVE INVESTIGATION.