Arcos Modular Revision Hip System 11-301024Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304474550), received between Nov 18, 2019 and Dec 8, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Implant subsidence” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Implant subsidence1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Packaging Problem1
Patient problems
- Aseptic loosening1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2025Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence
MalfunctionNov 18, 2019Packaging Problem; Packaging Problem
IT WAS REPORTED DURING THE DISTRIBUTION PROCESS PACKAGING DAMAGE WITH STERILITY BARRIER POTENTIALLY COMPROMISED WAS IDENTIFIED. NO PATIENT OR SURGICAL INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 9334517 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.