ECHO BI-METRIC HIP SYSTEM 192112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304463400), received between Jun 25, 2020 and Jun 25, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2020Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO THE STEM FRACTURING JUST BELOW THE HEAD. DURING THE PROCEDURE THE STEM COMPONENT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 10194363 ↗

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