ATTUNE 1506-70-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295492047), received between Jan 24, 2020 and Dec 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K170806, K233980); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE FIRST DAY AFTER SURGERY, A FOLLOW-UP ULTRASOUND WAS PERFORMED ON THE RIGHT LOWER LIMB BLOOD VESSELS, AND THE RESULTS SHOWED PARTIAL INTRAMUSCULAR VEIN THROMBOSIS AND POSTERIOR TIBIAL VEIN THROMBOSIS IN THE RIGHT LOWER LIMB.

  Patient problems: Loss of Range of Motion; Thrombosis/Thrombus

  MAUDE report 18314758 ↗
• InjurySep 29, 2022Migration; Migration

  PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE AND POOR BONE QUALITY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15503421 ↗
• InjuryJan 24, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  ATTUNE FIXED BEARING PS KNEE WAS REMOVED DUE TO GROSS MAL ALIGNMENT. TIBIAL COMPONENT WAS WELL FIXED, FEMORAL COMPONENT WAS WELL FIXED. PATELLA WAS LEFT IN. NEW CUTS WERE MADE, AND A SIGMA REVISION WAS PUT IN.

  Patient problems: No Code Available

  MAUDE report 9628995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170806, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1314-2021 · Feb 22, 2021 · Terminated
  ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee