Echo® Bi-Metric® Hip System 192410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868260711), received between Aug 24, 2020 and Nov 2, 2022 — 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.

• InjuryNov 2, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 10 DAYS POST IMPLANTATION DUE TO THE STEM COMPONENT SUBSIDING WHICH CAUSED A PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 15716381 ↗
• 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 10443443 ↗

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