ECHELON 71341024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010440280), received between May 23, 2019 and Sep 26, 2022 — classified as 2 injuries.

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

• InjurySep 26, 2022Biocompatibility; Migration; Biocompatibility; Migration

  IT WAS REPORTED THAT AFTER A RIGHT MOM-THR HAD BEEN PERFORMED, PATIENT EXPERIENCED COBALT LEVELS AT 270 (H) AND CHROMIUM LEVELS AT 31.0 (H). THERE WAS AN INCREASED SUBSIDENCE OF THE FEMORAL STEM WHEN COMPARED WITH PREVIOUS, WHICH RAISED SUSPICION FOR COMPONENT LOOSENING. THERE WERE DEGENERATIVE CHANGES IN LOWER LUMBER SPINE AND AT THE SACROILIAC JOINTS. SCLEROSIS ABOUT SYMPHYSIS PUBIS LIKELY REFLECTING LONG-STANDING STRESS-RELATED CHANGES, AS WELL AS DEGENERATIVE CHANGES IN THE LOWER LUMBER SPINE AND AT THE SACROILIAC JOINTS. SCLEROSIS ABOUT SYMPHYSIS PUBIS LIKELY REFLECTING LONG-STANDING STRESS-RELATED CHANGES. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 15483676 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MILDLY DISPLACED FRACTURE OCCURRED THROUGH THE OSTEOTOMY SITE OF THE LEFT GREATER TROCHANTER.

  Patient problems: Bone Fracture(s)

  MAUDE report 8638425 ↗

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.