ECHELON 71340111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010328700), received between Oct 23, 2018 and Sep 28, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT FELL AND EXPERIENCED PAIN, ON (B)(6) 2021. X-RAYS DETERMINED THE BREAK OF ECHELON POR 190MM STR SIZE 11 AND PATIENT IS SCHEDULED FOR A REVISION SURGERY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. REVISION SURGERY DATE TO BE PERFORMED, IS UNKNOWN

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12541632 ↗
• InjuryNov 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN COMPONENT. THE PREVIOUS REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. ON (B)(6) 2019, THE PATIENT COMPLAINED THAT FEMORAL STEM WAS BROKEN.

  Patient problems: Injury

  MAUDE report 9315168 ↗
• InjuryJan 2, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN PROSTHESIS.

  Patient problems: Injury

  MAUDE report 8210007 ↗
• InjuryOct 23, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT STOOD UP FROM A SEATING POSITION, AND FELT THE HIP FAIL "WITH A LOAD NOISE", AND IMPLANT FRACTURED.

  Patient problems: Injury

  MAUDE report 7995289 ↗

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.