Echo® Bi-Metric® Hip System 192113Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868260599), received between Feb 7, 2021 and Aug 5, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection; Necrosis; Pain; Scar Tissue

  MAUDE report 22722647 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT RECEIVED A CORTISONE INJECTION APPROXIMATELY THREE MONTHS POST IMPLANTATION FOR LATERAL HIP PAIN AND TROCHANTERIC BURSITIS. THEN AGAIN ONE YEAR POST IMPLANTATION DUE TO MILD PAIN, MODERATE DIFFICULTIES WITH ADL¿S, SNAPPING SENSATION AND DIFFICULTY SLEEPING. THE PATIENT WAS PRESCRIBED A CORTICOSTEROID INJECTION IN THE RIGHT TROCHANTERIC BURSA, VOLTAREN GEL AND A PRESCRIPTION FOR PT, POSSIBLY DRY NEEDLING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bursitis; Pain; Swelling/ Edema

  MAUDE report 19222874 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Seroma

  MAUDE report 12614777 ↗
• InjuryFeb 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT PRIMARY TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED EXTERNAL ROTATOR MUSCLE RUPTURE AND UNDERWENT RE-SUTURE REPAIR APPROXIMATELY ONE YEAR POST IMPLANTATION. NO IMPLANTS WERE REMOVED OR EXCHANGED, AND REMAINS IMPLANTED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Pain; Tissue Damage

  MAUDE report 11290488 ↗

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