ATTUNE 1504-11-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295041979), received between Jun 19, 2025 and Jun 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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

Recent adverse event reports

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

• MalfunctionJun 19, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A TKA SURGERY FOR OSTEOARTHRITIS OF THE LEFT KNEE. WHEN A NURSE OPENED THE IMPLANT, THE PLASTIC PART OF THE CASING INSIDE THE OUTER BOX WAS FOUND TO BE DEFORMED AND MUSHY, AS IF IT HAD BEEN MELTED BY HEAT. AFTER CHECKING, THE SURGEON DETERMINED THAT THERE WAS NO IMPACT ON THE STERILITY OF THE IMPLANT, SO THE SURGEON USED THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE ACTUAL CASING WILL BE RETURNED BY THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293829 ↗