ATTUNE 1516-30-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295047520), received between Jun 12, 2020 and Sep 19, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLYETHYLENE EXCHANGE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20257602 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021 LEFT KNEE,.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12541179 ↗
• InjuryJan 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED DUE TO GROSS INSTABILITY. REVISED FEMUR.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 11243979 ↗
• InjuryJan 4, 2021Unintended Movement; Unintended Movement

  BEARING SPUN OUT AND KNEE DISLOCATED. UPSIZED POLY.

  Patient problems: Joint Dislocation

  MAUDE report 11112349 ↗
• InjuryJun 12, 2020Unintended Movement; Unintended Movement

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT¿S LEFT KNEE JOINT. ON (B)(6) 2020, IT WAS CONFIRMED THAT THE SPIN-OUT OCCURRED. THE SECOND SURGERY WAS PLANNED ON (B)(6) 2020 BY REDUCTION OR REPLACING THE TIBIAL INSERT (P/N: 151630307). THERE WAS MALALIGNMENT OF TIBIA, AND THE IMPLANT WAS SET AS SLIGHTLY MEDIAL ROTATION POSITION. THERE WAS A POSSIBILITY WHICH THE BACKWARD OF THE BONE WAS CUT OBLIQUE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10149876 ↗