ATTUNE 2547-03-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295439523), received between Aug 24, 2018 and Jul 8, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Corroded” (5 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 22435478 ↗
• MalfunctionJul 16, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE AUGMENT IS CHIPPED AND WOULD NOT SLIDE INTO FEMUR TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330889 ↗
• MalfunctionDec 1, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE. THE ATTUNE REV DISTAL AUG 8 MM FOR 3- 4 DOESN'T SLIDE IN AND OUT OF FEMUR PROPERLY, LOOKS BENT. WHILE THE 1.5 MBT REV CLEAR TRIAL BROKE IN HALF, NO PIECES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894543 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002484 ↗
• MalfunctionFeb 11, 2021Break; Break

  INTRAOPERATIVELY THE AUGMENT´S TRIAL LITTLE PEG THAT CONNECTS WITH THE FEMORAL TRIAL BROKE OFF. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES, NO PART REMAINING IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313880 ↗
• 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 9184987 ↗
• 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 9184983 ↗
• MalfunctionJan 28, 2019Corroded; Problem with Sterilization; Corroded; Problem with Sterilization

  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. 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 8280875 ↗
• MalfunctionJan 28, 2019Corroded; Problem with Sterilization; Corroded; Problem with Sterilization

  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. 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 8280865 ↗
• 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 7814093 ↗
• 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 7814012 ↗