Arcos Modular Revision Hip System 11-301815Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Arcos Modular Revision Hip System (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304475144), received between Jul 13, 2021 and Oct 12, 2025 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration2
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Positioning Failure1
Patient problems
- Failure of Implant2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unequal Limb Length1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INACCURATE LEG LENGTH. THE CONE BODY, STEM AND HEAD WERE REVISED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unequal Limb Length
MAUDE report 23275461 ↗InjuryAug 28, 2024Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO MID-THIGH PAIN WITH STEM SUBSIDENCE. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: Failure of Implant; Pain
MAUDE report 20086076 ↗InjuryFeb 26, 2024Migration; Migration
IT WAS REPORTED THE PATIENT HAD AN INITIAL TOTAL LEFT HIP ARTHROPLASTY PERFORMED ON AN UNKNOWN DATE WITH UNKNOWN IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE ASSOCIATED WITH LOOSENING STEM. THE PATIENT WAS IMPLANTED WITH ZIMMER BIOMET DEVICES DURING THE REVISION SURGERY AND WAS REVISED FOR A SECOND TIME THREE YEARS POST IMPLANTATION FOR IMPLANT SUBSIDENCE.
Patient problems: Insufficient Information
MAUDE report 18779346 ↗InjuryMar 31, 2023Fracture; Fracture
MalfunctionJul 13, 2021Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12159651 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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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