Arcos Modular Revision Hip System 11-301301Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00880304468030), received between May 14, 2020 and May 28, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Implant subsidence” (2 reports).

2 FDA recall records 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. Jan 7, 2022Class IITerminated

   The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

   Z-0670-2022 · Root cause: Process control · Recall details · FDA record ↗

2. 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-2260-2021 · Root cause: Process control · Recall details · FDA record ↗

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 28, 2026Loosening of Implant Not Related to Bone-Ingrowth; Damaged Thread

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO MONTHS POST-IMPLANTATION. IT WAS NOTED, THE PROXIMAL BODY OR STEM SEEMS TO HAVE ROTATED, PLAN WAS TO REVISE PROXIMAL BODY HOWEVER THE PROXIMAL BODY COULD NOT BE MOVED, AND THE SCREW SEEMED CROSS THREADED, SO SURGEON REMOVED ENTIRE COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Aseptic loosening

  MAUDE report 25315563 ↗
• InjuryJul 29, 2025Inadequacy of Device Shape and/or Size; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence; Inadequacy of Device Shape and/or Size; Loosening of Implant Not Related to Bone-Ingrowth; Implant subsidence

  IT WAS REPORTED; PATIENT HAD A RIGHT PRIMARY HIP AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSE AND UNDERSIZED ARCOS STEM THAT HAS SUBSIDED. THE DISTAL TAPER, CONE BODY, HEAD, AND BEARING WERE EXPLANTED.

  Patient problems: Aseptic loosening

  MAUDE report 22643668 ↗
• 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 22319601 ↗
• MalfunctionDec 22, 2023Difficult to Remove; Difficult to Remove

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387530 ↗
• 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 15510574 ↗
• 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 15420967 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12920731 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 9 MONTHS¿ POST IMPLANTATION DUE TO JOINT SWELLING. THERE WAS NO COMPLICATION DURING THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling

  MAUDE report 10055328 ↗