ECHELON 71340115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010328748), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 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.

• InjuryAug 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT CAME FOR A FOLLOW UP VISIT ON (B)(6) 2021 WITH MARKED DISABILITY TO WALK, X RAY SHOWS CHANGE IN POSITION OF THE ECHELON 190MM POROUS FEMORAL COMPONENT SIZE 15 AND MRI ( MAVRIC) SHOWED IMPLANT LOOSENING. THERE WAS AN EDEMA IN THE FEMUR, DISTAL TO THE FEMORAL STEM. ALSO, THERE WAS THINNING OF THE FEMORAL CORTICES. PET CT WITH TRIPLE PHASE BONE SCAN WAS DONE AND CONFIRMED LOOSENING IN THE PRIMARY PATHOLOGY AND WAS NO INFECTION. REVISION SURGERY WAS PRESCRIBED TO REPLACE THE DEVICE BUT THE PATIENT HAS NOT AGREED TO IT YET. CURRENT HEALTH STATE OF THE PATIENT IS AMBULATORY WITH WALKER AND MOVING WITHIN THE HOUSE.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Inadequate Osseointegration; Swelling/ Edema

  MAUDE report 12317012 ↗

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.