ATTUNE 2545-05-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295481676), received between Apr 12, 2023 and Apr 25, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionApr 25, 2024Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188608 ↗
• MalfunctionMar 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE PS FEMORAL POSITIONAL WAS DAMAGED AFTER CLEANING IT. THE RUBBER LINING IN THE HOLES THAT CONNECT TO THE SHIMS IS FRAYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862024 ↗
• MalfunctionSep 5, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER A PRIMARY TOTAL KNEE ARTHROPLASTY, THE SPD MANAGER CONTACTED US TO INFORM US THAT A POSTERIOR STABILIZED FEMORAL POSITIONER WAS BROKEN. ONE OF THE HOLES WHERE THE SHIMS CLICKS IN WAS DAMAGED SUCH THAT THE SHIMS WOULD NO LONGER ATTACH. AS THIS WAS DISCOVERED AFTER THE SURGERY, THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682912 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE RUBBER SEALS IN ATTUNE PS FEMORAL POSITIONER WERE MISSING. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811349 ↗
• MalfunctionApr 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PRIMARY TOTAL KNEE ARTHROPLASTY, IT WAS FOUND THAT THE PS FEMORAL POSITIONER WAS DAMAGED SUCH THAT THE METAL SHIMS COULD NO LONGER BE CONNECTED TO IT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728822 ↗