Echo® Bi-Metric® Hip System 192009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868260407), received between Aug 24, 2020 and Feb 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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.

• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO A CLOSED NONDISPLACED OBLIQUE FRACTURE OF LEFT FEMUR FROM A MECHANICAL FALL. NO ADDITIONAL INFORMATION.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 13568081 ↗
• MalfunctionAug 24, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SURGEON REAMED AND BROACHED TO THE APPROPRIATE SIZE FOR THE IMPLANT BEING IMPLANTED. THE SURGEON INDICATED THE IMPLANTS DID NOT FIT THE SAME WAY THE BROACH FIT. EACH OF THE IMPLANTS INCLUDED IN THIS WERE IMMEDIATELY EXPLANTED UNTIL THE DESIRED FIT OF THE FINAL IMPLANT WAS ACHIEVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10443383 ↗

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