Arcos® Modular Revision System 31-301852Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887868477898), received between Feb 10, 2023 and May 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 reports).

18 other recalls cover devices cleared under the same FDA submission (K090757); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Fracture

  IT WAS REPORTED THAT TWO SCREWDRIVERS BROKE WHILE TRYING TO LOOSEN THE TRIAL ARCOS PROXIMAL BODY. NO PATIENT HARM OCCURRED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163934 ↗
• MalfunctionFeb 10, 2026Fracture

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307712 ↗
• MalfunctionSep 30, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183388 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547318 ↗
• MalfunctionJul 31, 2024Fracture; Fracture

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19872922 ↗
• MalfunctionJul 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY WHILE CLEANING THE PRODUCTS AFTER SURGERY, THE HEX SCREW DRIVER BROKE WHILE TRYING TO DISENGAGE THE CONE BODY FROM THE STEM. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654774 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DISASSEMBLY BOLT WORKED AS INTENDED DURING SURGERY. WHEN THE PROCEDURE WAS COMPLETED, THE DISASSEMBLY BOLT FROM THE PROXIMAL BODY HAD CROSS THREADED. THE PROXIMAL BODY-TIP OF 3.5 HEX DRIVER ALSO BROKE TRYING TO PROVIDE COUNTER TORQUE TO RELEASE DISASSEMBLY BOLT FROM PROXIMAL BODY. THE PATIENT WAS NO AFFECTED IN ANY WAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072353 ↗
• MalfunctionSep 13, 2023Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE THE SCREWDRIVER BROKE INSIDE THE CONE BODY. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739374 ↗
• MalfunctionApr 13, 2023Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735089 ↗
• MalfunctionMar 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE TIGHTENING THE TRIAL CONE TO THE DISTAL BODY THE HEX DRIVER TIP BROKE OFF. THE BROKEN PIECE WAS LOCATED AND REMOVED FROM THE FIELD. THERE WERE NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466109 ↗
• MalfunctionFeb 10, 2023Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353090 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090757. One submission often covers many models, so check the product and lot details in each record.

• Z-2275-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
• Z-2273-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
• Z-2269-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
• Z-2261-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
• Z-2272-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
• Z-2270-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
• Z-2268-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
• Z-2265-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
• Z-2267-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
• Z-2271-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
• Z-2274-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
• Z-2266-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
• Z-2260-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
• Z-2259-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
• Z-2263-2021 · Jun 2, 2021 · Terminated
  Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311

…and 3 more.