ECHELON 71340412Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010383945), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K983834); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER A PRIMARY LEFT TOTAL HIP ARTHROPLASTY HAD BEEN PERFORMED, THE PATIENT FELL DOWN AND EXPERIENCED A VANCOUVER TYPE B3 PERIPROSTHETIC FRACTURE. THEREFORE, A REVISION SURGERY WAS PERFORMED IN ORDER TO SOLVE THIS ADVERSE EVENT, AND IT WAS FOUND THAT THE ACETABULAR COMPONENT WAS STABLE, BUT THE FEMORAL COMPONENT WAS REVISED WITH AN ECHELON 260MM POROUS BOWED FEMORAL COMPONENT STANDARD COLLAR SIZE 12 LEFT. ON SIXTH WEEK CONTROL, IT WAS FOUND ON X-RAYS THAT THE ECHELON 260MM POROUS BOWED FEMORAL STEM IS BENDING. IT IS UNKNOWN IF ANY INTERVENTION HAS BEEN PERFORMED. IT IS UNKNOWN IF A SECOND REVISION SURGERY HAS BEEN SCHEDULED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13499022 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K983834. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.