ECHELON 71341011Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010438751), received between Aug 3, 2018 and Oct 30, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN ECHELEON FEMORAL STEM DUE TO COMPLICATIONS WITH IT. THE PRIMARY SURGERY WENT SUCCESSFULLY BUT IMMEDIATELY AFTER THE COMPLETION OF SUCH SURGERY IMAGING REVEALED THAT THERE WAS A PERFORATION OF THE FEMORAL STEM THROUGH THE PROXIMAL FEMORAL SHAFT. THE EVENT WAS RESOLVED VIA REVISION SURGERY IN WHICH THE STEM AND THE HEAD WERE REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 10766577 ↗
• InjuryOct 13, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN ECHELON FEMORAL STEM DUE TO COMPLICATIONS WITH IT. THE PRIMARY SURGERY WENT SUCCESSFULLY BUT AFTER THE COMPLETION OF SUCH SURGERY THE PATIENT HAD TO RETURN DUE TO A FEELING OF PAIN. UPON CHECKING X RAYS IT WAS NOTICED THAT THE PREVIOUSLY IMPLANTED STEM HAD PERFORATED TROUGH THE PROXIMAL FEMORAL SHAFT AND A REVISION WAS PLANNED IMMEDIATELY TO PRECLUDE ANY FURTHER DAMAGE. BOTH THE HEAD AND THE STEM WERE REVISED.

  Patient problems: Hip Fracture

  MAUDE report 10671981 ↗
• InjuryMay 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE ECHELON FEMORAL COMPONENT BROKE IN THE FEMORAL CANAL AS SHOWN BY X-RAY IMAGES. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE BROKEN PROSTHESIS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10065516 ↗
• InjurySep 21, 2018Break; Break

  IT WAS REPORTED THAT A CT SCAN WAS REQUIRED DUE TO A BROKEN INTERNAL LEFT HIP PROSTHESIS.

  Patient problems: Injury

  MAUDE report 7900144 ↗
• InjurySep 21, 2018Break; Break

  IT WAS REPORTED A CRP AND A BONE SCAN TRIPHASIC INJECTION/MDP WAS REQUIRED DUE TO A BROKEN INTERNAL LEFT HIP PROSTHESIS.

  Patient problems: Injury

  MAUDE report 7900083 ↗
• InjuryAug 3, 2018Break; Break

  IT WAS REPORTED THAT THE ECHELON STEM IMPLANT FRACTURED AFTER SURGERY.

  Patient problems: Injury

  MAUDE report 7749332 ↗

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.