ECHO BI-METRIC HIP SYSTEM 192508Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Echo Bi-Metric Hip System (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304462908), received between Aug 20, 2021 and Aug 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
Device problems
- Defective Device1
- Difficult to Insert1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2021Difficult to Insert; Defective Device; Difficult to Insert; Defective Device
IT WAS REPORTED DURING THE INITIAL LEFT HIP STEM IMPLANTATION, THE STEM BECAME STUCK AND NEEDED TO BE REMOVED. THE SURGEON COULD NOT ATTACH THE THREADED REMOVAL TOOL INSTRUMENT IN TO THE STEM AND IT WAS FOUND THAT SOMETHING MUST HAVE BEEN LEFT IN THE STEM FROM MANUFACTURING. THE SURGERY WAS COMPLETED WITH A NEW IMPLANT. A DELAY OF TEN MINUTES WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 12347584 ↗
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 · TerminatedECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
- Z-0300-2018 · Jun 5, 2017 · TerminatedECHO POR FMRL NC 9X125, model # 192009
- Z-0442-2013 · Nov 6, 2012 · TerminatedEcho Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoar
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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