ARCOS MODULAR REVISION SYSTEMRecalls & reported problems across all models
Biomet Orthopedics, LLC · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 14 models of ARCOS MODULAR REVISION SYSTEM by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2019 and May 13, 2026 — classified as 1 injury, 70 malfunctions.
The most frequently reported specific device problem is “Fracture” (57 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ARCOS MODULAR REVISION SYSTEM problems
Device problems
- Fracture57
- Difficult to Insert6
- Material Deformation2
- Physical Resistance/Sticking2
- Adverse Event Without Identified Device or Use Problem1
- Damaged Thread1
- Difficult to Advance1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
- Unspecified Infection1
ARCOS MODULAR REVISION SYSTEM models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ARCOS MODULAR REVISION SYSTEM 31-301852Prosthesis, hip, constrained, cemented or uncemented, metal/polymer46 reports
- Arcos® Modular Revision System 31-301852Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented11 reports
- ARCOS MODULAR REVISION SYSTEM 31-301000Prosthesis, hip, constrained, cemented or uncemented, metal/polymer3 reports
- ARCOS MODULAR REVISION SYSTEM 31-301858ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ARCOS MODULAR REVISION SYSTEM 31-301321Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- ARCOS MODULAR REVISION SYSTEM 31-301856ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ARCOS MODULAR REVISION SYSTEM 31-301857ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- ARCOS MODULAR REVISION SYSTEM 31-301310Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- ARCOS MODULAR REVISION SYSTEM 31-301302PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- ARCOS MODULAR REVISION SYSTEM 31-301300Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- ARCOS MODULAR REVISION SYSTEM 31-301312Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- ARCOS MODULAR REVISION SYSTEM 31-301301Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 report
- Arcos® Modular Revision System 31-301300Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Arcos® Modular Revision System 31-301856Orthopedic manual surgical instrument1 report
Recent ARCOS MODULAR REVISION SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Fracture
IT WAS REPORTED THAT TWO SCREWDRIVERS BROKE WHILE TRYING TO LOOSEN THE TRIAL ARCOS PROXIMAL BODY. NO PATIENT HARM OCCURRED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164280 ↗MalfunctionMay 13, 2026Fracture
IT WAS REPORTED THAT TWO SCREWDRIVERS BROKE WHILE TRYING TO LOOSEN THE TRIAL ARCOS PROXIMAL BODY. NO PATIENT HARM OCCURRED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163934 ↗MalfunctionFeb 10, 2026Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24307712 ↗MalfunctionOct 6, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23220355 ↗MalfunctionSep 30, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23183388 ↗MalfunctionJun 9, 2025Fracture; Fracture
IT WAS REPORTED THAT WHEN WHILE TIGHTENING THE PROVISIONAL CONE BODY ONTO THE STS STEM, THE 3.5 HEX TIP BROKE OFF. IT WAS A CLEAN BREAK RESULTING IN ONLY 2 PIECES. BOTH PIECES WERE RETRIEVED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22169446 ↗MalfunctionMay 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE HEX FRACTURED OFF IN THE CONE BODY TRIAL. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026097 ↗MalfunctionMar 20, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652270 ↗MalfunctionFeb 19, 2025Separation Problem; Damaged Thread; Separation Problem; Damaged Thread
IT WAS REPORTED THAT DISASSEMBLY TOOL AS COLD WELDED ONTO THE ARCOS PROXIMAL BODY IT REMOVED. THE DISASSEMBLY TOOL CANNOT BE REMOVED FROM THE ARCOS PROXIMAL BODY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21415026 ↗MalfunctionNov 19, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20722380 ↗MalfunctionOct 28, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547318 ↗MalfunctionAug 22, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRIVER WAS OFF AND REMAILED IN THE TRIAL. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031227 ↗MalfunctionJul 31, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19872922 ↗MalfunctionJul 23, 2024Fracture; Fracture
IT WAS REPORTED THE PROXIMAL BODY TRIAL WAS BROKEN. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19806244 ↗MalfunctionJul 3, 2024Fracture; Fracture
IT WAS REPORTED THAT THE 3.5 HEX SCREWDRIVER BROKE. 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. NO ADDITIONAL INFORMATION AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667617 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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