InjuryLWJ
BIOLOX® FORTE
Received Jul 7, 2026
Report 3005673311-2026-00135 · MDR key 25734526
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Manufacturer
Aesculap AgModel number
NK562Catalog number
NK562
Product problems
- Fracture
Patient
NA · Male
- Insufficient Information
Narrative
Description of Event or Problem
AN ADVERSE EVENT WAS REPORTED INVOLVING THE AESCULAP KNEE IMPLANTS. SPECIFICALLY, IT WAS REPORTED THAT FOLLOWING HIP SURGERY IN 2017, THE PATIENT EXPERIENCED A FALL. SUBSEQUENT EVALUATION REPORTEDLY IDENTIFIED A FRACTURE OF THE IMPLANTED MEDICAL DEVICE. REVISION SURGERY IS REQUIRED. THE SURGERY WAS PERFORMED IN ARGENTINA, AT (B)(6) HOSPITAL, BUT THE PATIENT CURRENTLY LIVES AND IS IN (B)(6). THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).