Arcos Modular Revision Hip System 11-302101Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304474246), received between Apr 24, 2024 and Sep 23, 2025 — classified as 2 injuries.
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
- Migration or Expulsion of Device1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE FOLLOWED BY A REVISION DUE TO INFECTION. DURING THE REVISION, A TROCHANTERIC FRACTURE WAS FOUND AND A LARGE PLATE AND BOLT WERE PLACED, ALONG WITH CERCLAGE CABLES FOR FIXATION. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND SWELLING APPROXIMATELY NINE (9) MONTHS LATER, UNDERWENT A PROCEDURE FOR POSSIBLE REMOVAL. DURING THE PROCEDURE, THE SCREW WAS FOUND COMPLETELY LOOSE, THE PLATE WAS WELL FIXED, AND A PROXIMAL CERCLAGE WAS BROKEN. THE BOLT WAS REMOVED AND THE PLATE WAS RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema
MAUDE report 23125658 ↗InjuryApr 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 19174119 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
- DJO SURGICAL 540-00-000Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED64 reports
- Arcos Modular Revision Hip System 11-301321Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall7 reports
- DJO SURGICAL 540-01-001Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED55 reports
- Arcos Modular Revision Hip System 11-301302Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301343Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- ARROW IPN037140Teleflex Incorporated · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Arcos Modular Revision Hip System 11-301325Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 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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