ATTUNE 2549-03-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295439196), received between Aug 24, 2018 and Jul 8, 2025 — classified as 11 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 11 most recent of 11 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 22435581 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002255 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001744 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAD 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 9184978 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAD 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 9184956 ↗
• MalfunctionMar 27, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT THE POINT OF TRIALING THE IMPLANTS THE SURGEON NOTICED THAT SOME OF THE TRIAL AUGMENTS HAD LOST SOME OF THEIR MAGNETISM. THESE AUGMENTS ARE STILL FUNCTIONAL. THE PROBLEM APPEARS TO BE WITH THE SIZE 3/4 4MM AND 8MM POSTERIOR TRIAL AUGMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457767 ↗
• MalfunctionMar 27, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT THE POINT OF TRIALING THE IMPLANTS THE SURGEON NOTICED THAT SOME OF THE TRIAL AUGMENTS HAVE LOST SOME OF THEIR MAGNETISM. THESE AUGMENTS ARE STILL FUNCTIONAL. THE PROBLEM APPEARS TO BE WITH THE SIZE 3/4 4MM AND 8MM POSTERIOR TRIAL AUGMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457764 ↗
• 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 8279510 ↗
• 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 8279490 ↗
• 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 7814075 ↗
• 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 7814068 ↗