ARCOS ONE-PIECE REVISION SYSTEM 110024780Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304700482), received between Jun 9, 2020 and Oct 9, 2024 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture7
Patient problems
- Foreign Body In Patient3
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY THE STEM INSERTER TIP BROKE OFF INTO THE STEM. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407206 ↗MalfunctionMar 11, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874780 ↗InjuryNov 6, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 18073852 ↗InjuryJan 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE SURGERY, THE TIP ON THIS COMPLAINT HANDLE WAS FRACTURED, AND THE FRACTURED PIECE OF HANDLE REMAINED IN THE STEM. THE SURGEON DECIDED TO FINISH THE SURGERY WITHOUT REMOVING THE FRACTURED PIECE OF HANDLE FROM THE PATIENT'S BODY. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 16088807 ↗MalfunctionJul 19, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A HIP REVISION SURGERY, THE INSERTER FRACTURED. THERE WAS NO ADVERSE EVENTS AS A RESULT OF THE MALFUNCTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15052431 ↗MalfunctionFeb 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 11324335 ↗MalfunctionJun 9, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 10134186 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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