ATTUNE 1516-30-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295047674), received between Jun 15, 2018 and Dec 3, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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

• InjuryDec 3, 2019Device Dislodged or Dislocated; Naturally Worn; Unintended Movement; Device Dislodged or Dislocated; Naturally Worn; Unintended Movement

  DER STATES THAT PATIENT WAS REVISED FOR SUSPECTED LOOSENING OF FEMUR AND TIBIA, AND TO RULE OUT INFECTION. NO INFECTION WAS SEEN FROM PATHOLOGY. LOOSENING INTERFACE OCCURRED IN CEMENT TO IMPLANT INTERFACE, CEMENT USED WAS A DEPUY PRODUCT. DOI: (B)(6) 2016; DOR: (B)(6) 2018.

  Patient problems: No Code Available; Pain

  MAUDE report 9401981 ↗
• InjuryJun 15, 2018Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  RECEIVED MEDICAL RECORDS ON 05/18/2018. RECORDS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS RIGHT KNEE PAIN, MID-FLEXION INSTABILITY, AND TIBIAL BASE PLATE AND FEMUR IMPLANT LOOSENING. SURGEON INDICATED THAT THE TIBIA COMPLETELY DEBONDED FROM THE CEMENT MANTLE. THE FEMUR WAS PARTIALLY DEBONDED, BUT NOT TO THE DEGREE OF THE TIBIA. THE TIBIAL INSERT WAS FOUND TO BE ROTATED 180 DEGREES FROM NORMAL ORIENTATION. THERE WAS SIGNIFICANT WEAR ON THE POSTERIOR ASPECT OF THE POLYETHYLENE TIBIA INSERT. THE PATELLA WAS WELL-FIXED. TIBIA, FEMUR, PATELLA, AND INSERT WERE ALL REVISED. DOI: (B)(6) 2016; DOR: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: Not Applicable; Pain

  MAUDE report 7604789 ↗