Arcos Modular Revision Hip System 11-301414Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304473904), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY WITH UNCEMENTED COMPETITOR IMPLANTS ON AN UNKNOWN DATE. IN AN UNKNOWN TIMEFRAME POSTOP, THE PATIENT FELL AND EXPERIENCED A PERIPROSTHETIC FRACTURE WITH LOOSENING OF THE FEMORAL COMPONENT. THE PATIENT UNDERWENT REVISION OF THE FEMORAL COMPONENTS WITH IMPLANTATION OF ZB COMPONENTS AND RETENTION OF THE INITIAL CUP AND LINER. THE FRACTURE WAS STABILIZED WITH FIBER TAPE AND CERCLAGE WIRES, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. SUBSEQUENTLY, THE PATIENT RETURNED FOR A SECOND REVISION TWO YEARS POST IMPLANTATION DUE TO LOOSENING AND SUBSIDENCE OF THE FEMORAL STEM. DURING THE REVISION, THE STEM AND HEAD WERE REPLACED, AND THE INITIAL CUP AND LINER WERE RETAINED.
Patient problems: Insufficient Information
MAUDE report 18847361 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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