Arcos® One-piece Revision System 11-304016Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304690936), received between Apr 2, 2024 and Apr 2, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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
- Inadequacy of Device Shape and/or Size2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT WHEN THE IMPLANTS WERE OPENED, THEY WERE FOUND TO BE UNDERSIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19019071 ↗MalfunctionApr 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT WHEN THE IMPLANTS WERE OPENED, THEY WERE FOUND TO BE UNDERSIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19019063 ↗
Other Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices
- G7® Acetabular System 010000664Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented20 reports
- G7 ACETABULAR SCREW 010000999Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7® Acetabular System 110010245Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7 Acetabular Liner 010000850Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented15 reports
- G7® Acetabular System 010000661Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7® Acetabular System 110010242Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7 Acetabular Liner 010000937Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented1 death12 reports
- G7 OSSEOTI ACETABULAR SHELL 110010243Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented10 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.
How reports and recalls are matched · Editorial policy · Report an error on this page