Arcos Modular Revision Hip System 11-301310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304473799), received between Nov 13, 2020 and May 15, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 2, 2021Class IITerminated

   Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

   Z-2262-2021 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-HIP PROCEDURE, THE PATIENT PRESENTED WITH SEPTIC SHOCK DUE TO MRSA INFECTION IN THE HIP. THEY HAD FEVERS, DIFFICULTY WALKING, SWELLING, ABSCESS, AND POSITIVE CULTURES FOR MRSA AND SEPTIC SHOCK. THE HEAD WAS EXCHANGED IN AN I&D PROCEDURE BEFORE THE STAGE ONE REVISION ONE MONTH LATER. OP RECORDS NOTE PURULENT FLUID, LARGE FASCIAL DEHISCENCE. ALL COMPONENTS WERE REPLACED WITH A CEMENT SPACER DURING STAGE ONE WITHOUT COMPLICATIONS. THE STAGE TWO REVISION TOOK PLACE FOUR MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abscess; Ambulation or Postural Difficulties; Bacterial Infection; Medical device site infection; Purulent Discharge; Scar Tissue; Sepsis; Septic Shock; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25184346 ↗
• 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 25148170 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 23592449 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23310526 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 20367961 ↗
• MalfunctionApr 17, 2023Difficult to Insert; Difficult to Insert

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755673 ↗
• InjuryAug 10, 2021Unstable; Migration; Physical Resistance/Sticking; Unstable; Migration; Physical Resistance/Sticking

  IT WAS REPORTED THE PATIENT UNDERWENT REVISION RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO STEM SUBSIDENCE AND RECURRENT DISLOCATION. THE SURGEON REPORTED SIGNIFICANT SCARRING AND WAS UNABLE TO DISENGAGE THE PROXIMAL BODY FROM THE STEM. ALL DEVICES WERE REMOVED AND REPLACED EXCEPT FOR THE CUP WHICH REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain; Scar Tissue; Swelling/ Edema; Unequal Limb Length

  MAUDE report 12302940 ↗
• MalfunctionJul 13, 2021Positioning Failure; Positioning Failure

  UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159645 ↗
• InjuryNov 13, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO THE RUPTURE OF THE ARCOS CONE PROXIMAL BODY WITH STS DISTAL STEM AS A RESULT OF A FALL. NO ADDITIONAL INFORMATION.

  Patient problems: Fall

  MAUDE report 10837283 ↗