Arcos Modular Revision Hip System 11-301303Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304474130), received between Dec 31, 2021 and May 20, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 25230147 ↗
• MalfunctionJan 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROXIMAL PART OF THE IMPLANT FAILED TO CONNECT TO THE DISTAL PART. A LARGER ONE (70MM) WAS USED TO CONTINUE THE PROCEDURE WITH THE SAME DISTAL STEM. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137624 ↗
• MalfunctionOct 16, 2024Difficult to Remove; Difficult to Remove

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466806 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 19671682 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 19518618 ↗
• MalfunctionMay 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352292 ↗
• InjurySep 14, 2023Migration; Migration

  IT WAS REPORTED THAT DURING A REVISION OF UNKNOWN DEVICES, THE DOCTOR NOTED THAT THE ACETABULUM WAS NOT PREPARED CORRECTLY; THEREFORE, INSERTED THE CUP WITH FIXATION OF FOUR SCREWS. DURING THE ATTEMPTS OF REDUCTION, ENCOUNTERED DIFFICULTY AND UPON DELIVERY OF FORCE, LED TO ROTATION OF THE PRESS-FIT FEMORAL STEM. A CURVED STEM WAS THEN PLACED AND AS ADDITIONAL REDUCTION ATTEMPTS WERE MADE, THE STEM ALSO ROTATED, LEADING TO THE STEM BEING CEMENTED. IN THE PROCESS OF TESTING THE HIP, ONE EVENT OF DISLOCATION OCCURRED; THEREFORE, ADDITIONAL REDUCTION MANEUVERS WERE REPEATED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSPORTED OUT OF THE OR. AFTER APPROXIMATELY 1 HOUR, THE PATIENT WAS RETURNED TO THE OR DUE TO DISLOCATION. THE LINER WAS REVISED TO A FREEDOM LINER AND WAS SUCCESSFULLY REDUCED WITHOUT DISLOCATION. SUBSEQUENTLY, DUE TO THE USE OF TENSILE FORCE, THE CUP DETACHED FROM THE ACETABULAR WALL AND THE PATIENT WAS HOSPITALIZED HIP PENDENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 17744747 ↗
• InjuryDec 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION SURGERY 3 MONTHS¿ POST IMPLANTATION DUE TO NON-UNION IN MORBIDLY OBESE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13125177 ↗