ATTUNE 1520-21-005Recalls & reported problems

Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT AOX 10, 5mm · Class 2 · Implant

All models of ATTUNE (1475)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295542889), received between Feb 17, 2026 and Mar 31, 2026 — classified as 2 injuries.

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2

Patient problems

Unspecified Infection2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTED WITH POSSIBLE INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24745284 ↗
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24367772 ↗

Device details

UDI-DI	`10603295542889`
Brand	ATTUNE
Model	1520-21-005
Catalog no.	152021005
Company	Depuy (Ireland)
Product code	OIY · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
Class	Class 2
FDA submission	K211609, K253197
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 13, 2026

Device type (GMDN): Tibial insert

An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

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All Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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