ARCOS MODULAR REVISION SYSTEM 31-301000Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
All models of ARCOS MODULAR REVISION SYSTEM (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304490093), received between Nov 27, 2019 and May 28, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Advance1
- Material Deformation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE PROSTHESIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19404752 ↗MalfunctionJun 13, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE PROXIMAL BODY INSERTER WAS CROSS THREADED. THERE WAS NO IMPACT TO PATIENT AND NO ADVERSE CONSEQUENCES WERE REPORTED. DURING INVESTIGATION, THE THREADS WERE OBSERVED TO BE DAMAGED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14681089 ↗InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION. SUBSEQUENTLY, PATIENT UNDERWENT THIRD REVISION APPROXIMATELY ONE AND HALF YEARS POST INITIAL IMPLANTATION FOR INFECTION. ALL DEVICES WERE REMOVED AND REPLACED WITH CEMENT SPACERS. SALES REP INDICATES NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 9383137 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 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.
How reports and recalls are matched · Editorial policy · Report an error on this page