Echo® Bi-Metric® Hip System 192011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868260421), received between Apr 19, 2021 and Apr 1, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K070274); 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 18, 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.

• InjuryApr 1, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. FIVE DAYS POST OP, THE PATIENT DEVELOPED PAIN AND WAS UNABLE TO BEAR WEIGHT. THE PATIENT HAD NO TRAUMA OR FALLS POST INITIAL SURGERY. A SECONDARY X-RAYS SHOWED THAT THE STEM HAD SUBSIDED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 WEEKS POST IMPLANTATION. DURING THE SECONDARY PROCEDURE, A FRACTURE WAS FOUND, CABLED AND A BIGGER STEM WAS REAMED, BROACHED, AND INSERTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19012190 ↗
• MalfunctionApr 19, 2021Packaging Problem; Packaging Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070274. One submission often covers many models, so check the product and lot details in each record.

• Z-2821-2018 · Jun 8, 2018 · Terminated
  ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
• Z-0300-2018 · Jun 5, 2017 · Terminated
  ECHO POR FMRL NC 9X125, model # 192009
• Z-0442-2013 · Nov 6, 2012 · Terminated
  Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoar