Arcos Modular Revision Hip System 11-300815Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00880304474178), received between Nov 27, 2019 and May 20, 2026 — classified as 7 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
- Migration2
- Detachment of Device or Device Component1
- Fracture1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Manufacturing, Packaging or Shipping Problem1
- Unstable1
Patient problems
- Pain2
- Bone Fracture(s)1
- Failure of Implant1
- Fall1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Radiolucent Lines1
- Scar Tissue1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN AND RADIOLUCENCY OF COMPONENT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Pain; Radiolucent Lines
MAUDE report 25230117 ↗InjuryNov 18, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20706817 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 20076216 ↗InjuryAug 10, 2021Unstable; Migration; Unstable; Migration
IT WAS REPORTED THE PATIENT UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO STEM SUBSIDENCE AND RECURRENT DISLOCATION. THE SURGEON REPORTED SIGNIFICANT SCARRING AND WAS UNABLE TO DISENGAGE THE PROXIMAL BODY FROM THE STEM. ALL DEVICES WERE REMOVED AND REPLACED EXCEPT FOR THE CUP WHICH REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain; Scar Tissue; Swelling/ Edema; Unequal Limb Length
MAUDE report 12302994 ↗InjuryNov 20, 2020Fracture; Fracture
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO THE RUPTURE OF THE PROSTHESIS ARCOS CONE PROXIMAL BODY WITH STS DISTAL STEM. NO ADDITIONAL INFORMATION.
Patient problems: Fall
MAUDE report 10875997 ↗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 9383112 ↗InjuryNov 27, 2019Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Code Available
MAUDE report 9382366 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page