ATTUNE 2547-07-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295439431), received between Aug 24, 2018 and May 14, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Corroded” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS SHOW RUSTING AND DISCOLOURATION ON PRODUCTS' INFORMATION. THE PRODUCT DAMAGE HAS BEEN 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 22021248 ↗
• MalfunctionMay 14, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS SHOW RUSTING AND DISCOLOURATION ON PRODUCTS' INFORMATION. THE PRODUCT DAMAGE HAS BEEN 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 22021242 ↗
• 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 22011816 ↗
• 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 22011705 ↗
• 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 22005156 ↗
• 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 22005146 ↗
• 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 21986883 ↗
• 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 21986813 ↗
• 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 21903302 ↗
• 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 21898745 ↗
• 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 21898743 ↗
• 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 21893416 ↗
• 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 21893372 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186337 ↗
• MalfunctionOct 14, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186324 ↗
• 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 8279288 ↗
• 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 8279272 ↗
• 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 7813963 ↗
• 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 7813948 ↗