Arcos Modular Revision Hip System 11-300816Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304474239), received between Jan 10, 2022 and Jun 12, 2026 — classified as 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE NEW PROSTHESIS, A DISTAL FEMORAL FRACTURE OCCURRED, AND THE CANAL WAS STABILIZED BEFORE PROCEEDING. THE PATIENT SUSTAINED AN INTRA-OPERATIVE DISTAL FEMORAL FRACTURE THAT WAS TREATED WITH CABLE FIXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Periprosthetic fracture

  MAUDE report 25484651 ↗
• InjuryMay 12, 2026Separation Failure

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SCREWDRIVER TIP BROKE OFF IN THE PROXIMAL BODY WHILE TORQUING THE BODY TO THE DISTAL STEM. THE BROKEN PIECE WAS UNABLE TO BE REMOVED. THE PROXIMAL BODY WAS ALSO UNABLE TO BE REMOVED FROM THE DISTAL STEM SO THE IMPLANTS REMAINED IN PLACE AND THE BROKEN PIECE WAS RETAINED IN THE PATIENT. THERE WAS APPROXIMATELY A TEN-MINUTE DELAY IN ATTEMPTING TO REMOVE THE BROKEN SCREWDRIVER TIP AND THE IMPLANTS. THERE HAS BEEN NO KNOWN IMPACT DUE TO THE RETAINED SCREWDRIVER TIP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25148112 ↗
• InjuryJun 24, 2025Implant subsidence; Implant subsidence

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 6 YEARS POST-IMPLANTATION DUE TO SUBSIDENCE, AMBULATION DIFFICULTIES, LIMPING, AND INSTABILITY. DURING THE REVISION NOTED SCAR TISSUE, SUBSIDENCE, AND SHORTENING MAKING IT HARD TO DISLOCATE THE HIP. THERE WAS ALSO 50% OF THE DISTAL CEMENTLESS STEM PROTRUDING OUTSIDE OF THE LATERAL CORTEX OF THE FEMUR, CAUSING A FRACTURE. IT WAS ALSO NOTED THAT THE PREVIOUS STEM WAS PLACED INTO AN INADEQUATE REMOVAL OF THE CEMENT FROM THE INTRAMEDULLARY CANAL AND IS THE REASON FOR THE GROSS FAILURE. THE SHELL WAS WELL FIXED AND REMAINED IMPLANTED WITH ALL OTHER COMPONENTS EXPLANTED WITHOUT COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Bone Fracture(s); Joint Laxity; Numbness; Pain; Scar Tissue

  MAUDE report 22319608 ↗
• InjuryJan 28, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252347 ↗
• MalfunctionMay 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS DIFFICULT TO FIX THE PROXIMAL BODY ONTO THE DISTAL STEM. THERE WAS A 35 MINUTE DELAY TO SURGERY. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352312 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING EXCRUCIATING PAIN AT SEVERAL FOLLOW UPS AFTER TOTAL HIP ARTHROPLASTY. THE PATIENT WAS TREATED WITH ANALGESIA AND THE PAIN HAS SINCE RESOLVED. THE DEVICES REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15510527 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED WOUND DEHISCENCE APPROXIMATELY 3 WEEKS AFTER A HIP REVISION. THE PATIENTS WOUND WAS REOPENED AND PROVIDED FLUXOCACILIN ORAL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Wound Dehiscence

  MAUDE report 15420959 ↗
• MalfunctionMar 23, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THE SCREW CONNECTING THE PROXIMAL BODY AND DISTAL STEM HAD A HARD TIME TIGHTENING AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869070 ↗
• MalfunctionJan 10, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE ARCOS 50MM PROXIMAL BODY CONE TRIAL WOULD NOT ENGAGE WITH THE STEM. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206109 ↗