ECHO 31-555619Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304466296), received between Aug 7, 2023 and Aug 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044357 ↗MalfunctionMay 21, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HIP SURGERY, THE STEM INSERTER THREADS SNAPPED OFF AFTER ONE MALLET STRIKE WHILE ATTEMPTING TO IMPLANT THE STEM. THE BROKEN THREADS WERE LODGED INSIDE THE IMPLANT. THERE WAS NO WAY TO GET THE BROKEN THREADS OUT, AND NO WAY TO SCREW A NEW INSERTER INTO THE STEM. THEREFORE, THE IMPLANT WAS WASTED, AND A NEW ONE WAS USED. IT WAS REPORTED THAT THE IMPLANT ITSELF WAS NOT DEFECTIVE, BUT THE INSERTER (INSTRUMENT) MAY HAVE BEEN. SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO PATIENT IMPACT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND NO SURGICAL COMPLICATIONS. FOREIGN BODY WAS NOT RETAINED. THERE WERE NO CONTRIBUTING CONDITIONS RELATED TO THE EVENT. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360175 ↗MalfunctionAug 7, 2023Fracture; Fracture
IT WAS REPORTED THAT THE ECHO BIMETRIC STEM INSERTER THREADS SHEARED OFF OF THE STEM IMPLANT DURING IMPACTING. THE PROCEDURE WAS COMPLETED USING ANOTHER STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17469814 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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