ARCOS MODULAR REVISION SYSTEM 31-301852Recalls & reported problems

All models of ARCOS MODULAR REVISION SYSTEM (14)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Biomet Arcos modular hip revision stem is used in joint replacement surgery. The 45 reports mostly describe the metal stem breaking during surgery — the hex tip snapping off the cone body or the screwdriver — and instruments jamming or wearing out during handling. No deaths and no injuries are described. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 46
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00880304484498), received between Aug 12, 2020 and May 13, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Fracture” (45 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture45
Mechanical Jam1
Naturally Worn1

Patient problems

No Clinical Signs, Symptoms or Conditions43
No Known Impact Or Consequence To Patient2
No Patient Involvement1

Recent adverse event reports

The 25 most recent of 46 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 25164280 ↗
MalfunctionOct 6, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23220355 ↗
MalfunctionJun 9, 2025Fracture; Fracture
IT WAS REPORTED THAT WHEN WHILE TIGHTENING THE PROVISIONAL CONE BODY ONTO THE STS STEM, THE 3.5 HEX TIP BROKE OFF. IT WAS A CLEAN BREAK RESULTING IN ONLY 2 PIECES. BOTH PIECES WERE RETRIEVED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22169446 ↗
MalfunctionMay 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE HEX FRACTURED OFF IN THE CONE BODY TRIAL. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026097 ↗
MalfunctionMar 20, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21652270 ↗
MalfunctionNov 19, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20722380 ↗
MalfunctionAug 22, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRIVER WAS OFF AND REMAILED IN THE TRIAL. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031227 ↗
MalfunctionJul 3, 2024Fracture; Fracture
IT WAS REPORTED THAT THE 3.5 HEX SCREWDRIVER BROKE. THERE WAS NO PATIENT IMPACT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION. THERE WAS NO SURGICAL DELAY AND NO SURGICAL COMPLICATIONS. FOREIGN BODY WAS NOT RETAINED. NO ADDITIONAL INFORMATION AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667617 ↗
MalfunctionJun 12, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520284 ↗
MalfunctionMar 7, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A LEFT HIP REVISION, THE SCREWDRIVER TORQUED, AND THE TIP SNAPPED OFF. AN ADDITIONAL TRAY WAS OPENED, AND A SECONDARY SCREWDRIVER WAS UTILIZED TO COMPLETE THE CASE. SURGICAL TECHNIQUE WAS USED. THERE WAS NO REPORTED PATIENT IMPACT, NO SURGICAL DELAY, AND NO FOREIGN BODY RETAINED. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18861609 ↗
MalfunctionJan 2, 2024Fracture; Fracture
IT WAS REPORTED THE HEX DRIVE BROKE DURING THE CASE. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18429281 ↗
MalfunctionDec 20, 2023Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18363056 ↗
MalfunctionNov 6, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18072377 ↗
MalfunctionOct 6, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17886145 ↗
MalfunctionAug 18, 2023Fracture; Fracture
IT WAS REPORTED THE SCREW TIP BROKE OFF WHILE UTILIZING TO ADJUST BODY VERSION. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17574248 ↗
MalfunctionAug 9, 2023Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17491114 ↗
MalfunctionJul 14, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325514 ↗
MalfunctionJul 13, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315085 ↗
MalfunctionJun 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SCREW DRIVER BROKE WHILE SCREWING ON PROXIMAL BODY TRIAL. THE TRIAL WAS REMOVED AND NOT USED FOR THE REST OF THE CASE. 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 17163164 ↗
MalfunctionMay 8, 2023Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16888623 ↗
MalfunctionMay 2, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE 3.5MM HEX SCREWDRIVER USED TO TIGHTEN WAS WORN TO BEGIN WITH, AND UNABLE TO LOOSEN CONE BODY TRIAL FROM DISTAL STEM IMPLANT. 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 16854027 ↗
MalfunctionApr 24, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SCREWDRIVER WAS FRACTURED. THIS EVENT DID NOT OCCUR DURING A SURGERY AND NO PATIENT INVOLVEMENT WAS REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16798556 ↗
MalfunctionApr 13, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16731381 ↗
MalfunctionMar 28, 2023Fracture; Fracture
NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16630170 ↗
MalfunctionMar 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE HEX DRIVER BROKE WHILE TIGHTENING THE PROXIMAL BODY TRIAL. THERE WAS A LESS THAN 5 MINUTE DELAY TO REMOVE THE BROKEN HEX HEAD. NO FOREIGN BODY REMAINED IN THE PATIENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16573610 ↗

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-2268-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
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-2269-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
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-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-2263-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
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-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-2260-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Z-2264-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
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-2259-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
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-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-2272-2021 · Jun 2, 2021 · Terminated
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335

…and 3 more.

Device details

UDI-DI	`00880304484498`
Brand	ARCOS MODULAR REVISION SYSTEM
Model	31-301852
Company	Biomet Orthopedics, LLC
Product code	KWZ · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Class	Class 2
FDA submission	K090757
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 30, 2025

Device type (GMDN): Surgical screwdriver, reusable

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices

Novation 134-36-45
Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
2 recalls0 reports
PINNACLE 1218-28-650
Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
89 reports
Trident 690-00-28F
Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
1 recall37 reports
Trident 690-00-22E
Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
1 recall36 reports
PINNACLE 1218-32-652
Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
75 reports
Trident 690-00-22D
Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
1 recall22 reports
PINNACLE 1218-32-654
Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
70 reports
Trident 69-2850
Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
1 recall11 reports

All Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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