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ATTUNE 1516-50-316Recalls & reported problems

Depuy (Ireland) · ATTUNE KNEE SYSTEM TIBIAL INSERT ROTATING PLATFORM POSTERIOR STABILIZED SIZE 3 16mm AOX · Class 3 · Implant

All models of ATTUNE (1475)

Data updated Oct 18, 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 10603295052210), received between Nov 30, 2018 and Mar 10, 2020 — 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 18, 2026.

Most reported problems

Device problems

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

Patient problems

  • No Code Available1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT KNEE. DOI: (B)(6) 2020; DOR: (B)(6) 2020 LEFT KNEE.

    Patient problems: No Code Available; Pain

    MAUDE report 9815017 ↗
  • InjuryNov 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE PATIENT WAS REVISED DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 8121688 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices →

Sources and updates

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