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ATTUNE 1516-20-307Recalls & reported problems

Depuy (Ireland) · Attune Knee System TIBIAL INSERT FIXED BEARING CRUCIATE RETAINING 3 7mm AOX · Class 2 · Implant

All models of ATTUNE (1475)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295045427), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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

  • Insufficient Device Problem Information1

Patient problems

  • Not Applicable1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGED AND DEBRIDEMENT WITH RUPTURED PATELLA TENDON. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

    Patient problems: Not Applicable; Unspecified Infection

    MAUDE report 7874419 ↗

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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