ATTUNE 2549-05-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295439219), received between Aug 24, 2018 and Jul 8, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Corroded” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE STERILIZATION DEPARTMENT OF THE HOSPITAL NOTICED, DURING INSPECTION OF THE INSTRUMENTS, SOME STAINS ON SEVERAL THE INSTRUMENTS FOR AUGMENTATION (DISTAL & POSTERIOR) OF THE FEMORAL COMPONENT. IT LOOKS LIKE THERE IS SOME RUST FORMATION ON THE EDGE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22435723 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT THE 4MM POSTERIOR AUGMENT WAS USED DURING TRIALING AND BROKEN AFTER TRIALING. THE PATIENT WAS NOT AFFECTED AND THERE WAS NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588289 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002363 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002251 ↗
• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT WAS WORN ON ONE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976512 ↗
• MalfunctionJun 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THE MAGNETIC POSTERIOR AUGMENT ATTUNE REVISION TRIAL NO LONGER IS CONNECTING (MAGNETICALLY) TO THE TRIAL FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11994081 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING LEFT IN PATIENT. NASHVILLE LOANER 4 ATTUNE REVISION GENERAL FEMORAL PREP CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9185109 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING LEFT IN PATIENT. NASHVILLE LOANER 4 ATTUNE REVISION GENERAL FEMORAL PREP CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9185057 ↗
• MalfunctionJan 25, 2019Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material

  IN DEPUY LOANER DEPARTMENT METAL DEBRIS WAS SEEN ON FEMUR AUGMENTS OF THE ATTUNE REVISION SETS. ALL AUGMENTS WERE AFFECTED BUT DIFFERENT DEGREES. THE INSTRUMENTATION WAS READY PACKED FOR SHIPMENT. THE INSTRUMENTATION WAS SHIPPED A TOTAL OF 8 TIMES AND WAS THOROUGHLY CLEANED 3 TIMES WITH ALCOHOL BY AN ORTHOKIT OPERATOR. IN ADDITION, THERE ARE NOTICEABLE RUST MARKS, PROBABLY FROM THE ENGRAVING. THIS WAS SEEN INTERNALLY; NO PATIENT INVOLVEMENT, NO SURGERY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8279326 ↗
• MalfunctionJan 25, 2019Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material

  IN DEPUY LOANER DEPARTMENT METAL DEBRIS WAS SEEN ON FEMUR AUGMENTS OF THE ATTUNE REVISION SETS. ALL AUGMENTS WERE AFFECTED BUT DIFFERENT DEGREES. THE INSTRUMENTATION WAS READY PACKED FOR SHIPMENT. THE INSTRUMENTATION WAS SHIPPED A TOTAL OF 8 TIMES AND WAS THOROUGHLY CLEANED 3 TIMES WITH ALCOHOL BY AN ORTHOKIT OPERATOR. IN ADDITION, THERE ARE NOTICEABLE RUST MARKS, PROBABLY FROM THE ENGRAVING. THIS WAS SEEN INTERNALLY; NO PATIENT INVOLVEMENT, NO SURGERY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8279294 ↗
• MalfunctionAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TRIAL SHOWS MAGNETIC/METAL WEAR BEFORE USE. INSTRUMENT WAS WIPED B.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814085 ↗
• MalfunctionAug 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TRIAL SHOWS MAGNETIC/METAL WEAR BEFORE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814026 ↗