ECHO BI-METRIC HIP SYSTEM 192411Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304463431), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 injury.

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.

• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO WOUND DEHISCENCE AND DEEP HIP SEROMA WITH SWELLING AND SEROSANGUINEOUS FLUID APPROXIMATELY 2 WEEKS POST REVISION SURGERY. DURING THE REVISION TISSUE SENT FOR CULTURES, RESULTS PENDING, AND DEBRIDEMENT OF ADHESIONS. WOUND VAC PLACED AND IV ANTIBIOTICS UNTIL CULTURE IS NEGATIVE. STOPPED DVT ANTICOAGULANTS DUE TO WOUND COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 13826350 ↗

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