Echo® Bi-Metric® Hip System 192012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868260438), received between Jan 2, 2020 and May 20, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Erosion” (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 16, 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.

• InjuryMay 20, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT AFTER IMPLANTATION, THE PATIENT HAD ONGOING PAIN. PATIENT STARTED HAVING SWOLLEN LYMPH NODES AND HIGH WHITE BLOOD CELL COUNT MORE RECENTLY. PATIENT WAS DIAGNOSED WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND MARGINAL LYMPHOMA IN THE GROIN ONLY. PATIENT IS RECEIVING ONGOING DIAGNOSTICS. PATIENT WAS TOLD HE HAD HEAVY METAL POISONING TO ALUMINUM AND SEVERAL OTHER METALS. THE IMPLANT SURGEON¿S OFFICE INFORMED THE PATIENT TODAY THAT HIS FEMUR DEVICE CONTAINED ALUMINUM. PATIENT WAS INFORMED THAT HE LIKELY WILL REQUIRE A REVISION TO HAVE THE IMPLANTS REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: High White Blood Cell Count; Lymphoma; Metal Related Pathology; Pain; Swollen Lymph Nodes/Glands

  MAUDE report 19351828 ↗
• MalfunctionJan 2, 2020Packaging Problem; Packaging Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 9538936 ↗

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