ATTUNE 2547-06-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295439394), received between Aug 24, 2018 and May 13, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Corroded” (20 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT THE PRODUCT(S) HAS RUSTING AND DISCOLORATION. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011787 ↗
• MalfunctionMay 13, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT THE THE PRODUCT(S) HAS RUSTING AND DISCOLORATION. THE ISSUE WAS IDENTIFIED DURING LOAN KIT INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011314 ↗
• MalfunctionMay 12, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS IDENTIFIED THAT THE PRODUCT SHOWS RUSTING AND DISCOLORATION ON PRODUCT INFORMATION. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005157 ↗
• MalfunctionMay 12, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS IDENTIFIED THAT THE PRODUCT SHOWS RUSTING AND DISCOLORATION ON PRODUCT INFORMATION. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005149 ↗
• MalfunctionMay 8, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE AUGMENTS ARE RUSTING AROUND THE MAGNET AREA AND CANNOT BE CLEANED EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986840 ↗
• MalfunctionMay 8, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE AUGMENTS ARE RUSTING AROUND THE MAGNET AREA AND CANNOT BE CLEANED EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986709 ↗
• MalfunctionApr 25, 2025Corroded; Corroded

  ATUN REV DST F AUGTRL 16XSZ7-8 AND ATTUNE REV DST F AUGTRL 16XSZ6 HAVE POTENTIAL SURFACE RUST. THE PRODUCT DAMAGE DOCUMENTED IN PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911458 ↗
• MalfunctionApr 25, 2025Corroded; Corroded

  ATUN REV DST F AUGTRL 16XSZ7-8 AND ATTUNE REV DST F AUGTRL 16XSZ6 HAVE POTENTIAL SURFACE RUST. THE PRODUCT DAMAGE DOCUMENTED IN PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911256 ↗
• MalfunctionApr 24, 2025Corroded; Corroded

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE IN 2025, IT WAS IDENTIFIED THAT FEMORAL TRIALS HAVE POTENTIAL SURFACE RUST. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903300 ↗
• MalfunctionApr 24, 2025Corroded; Corroded

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE IN 2025, IT WAS IDENTIFIED THAT FEMORAL TRIALS HAVE POTENTIAL SURFACE RUST. THERE WAS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903298 ↗
• MalfunctionApr 24, 2025Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ATUN REV DST F AUGTRL 16XSZ7-8 AND ATTUNE REV DST F AUGTRL 16XSZ6 HAVE POTENTIAL SURFACE RUST. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898749 ↗
• MalfunctionApr 24, 2025Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ATUN REV DST F AUGTRL 16XSZ7-8 AND ATTUNE REV DST F AUGTRL 16XSZ6 HAVE POTENTIAL SURFACE RUST. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898747 ↗
• MalfunctionApr 23, 2025Corroded; Corroded

  ATUN REV DST F AUGTRL 16XSZ7-8 AND ATTUNE REV DST F AUGTRL 16XSZ6 POSSIBLE SURFACE RUST SURROUNDING MAGNETS. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIES DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893439 ↗
• MalfunctionApr 23, 2025Corroded; Corroded

  ATUN REV DST F AUGTRL 16XSZ7-8 AND ATTUNE REV DST F AUGTRL 16XSZ6 POSSIBLE SURFACE RUST SURROUNDING MAGNETS. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIES DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT AND ALERT DATE ARE THE DATE THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893407 ↗
• MalfunctionApr 10, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A TARNISHING WAS FOUND ON THE TOP AND BOTTOM OF THE TRIALS. IT WAS UNABLE TO REMOVE THROUGH STANDARD CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816852 ↗
• MalfunctionApr 10, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A TARNISHING WAS FOUND ON THE TOP AND BOTTOM OF THE TRIALS. IT WAS UNABLE TO REMOVE THROUGH STANDARD CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816847 ↗
• 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 9185143 ↗
• 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 9185131 ↗
• 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 8279495 ↗
• 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 8279466 ↗
• 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 7814095 ↗
• 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 7814050 ↗