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ATTUNE 1516-21-008Recalls & reported problems

Depuy (Ireland) · Attune Knee System TIBIAL INSERT FIXED BEARING CRUCIATE RETAINING 10 8mm AOX · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295046271), received between Mar 28, 2019 and Jul 30, 2021 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Joint Laxity1
  • No Consequences Or Impact To Patient1
  • Pain1

Recent adverse event reports

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

  • InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    OPERATIVE NOTES RECEIVED INDICATED THAT ON (B)(6) 2021, THE PATIENT HAD A REVISION OF THE RIGHT TOTAL KNEE TO ADDRESS LIGAMENTOUS LAXITY AND PAIN. THE TIBIAL INSERT WAS REVISED. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE.

    Patient problems: Joint Laxity; Pain

    MAUDE report 12253376 ↗
  • MalfunctionMar 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ATTUNE OUTSIZER KIT WAS FOUND TO HAVE EXPIRED IMPLANTS IN THE SET.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8460128 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices →

Sources and updates

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