ATTUNE 2545-00-713Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295133858), received between Oct 8, 2018 and Feb 5, 2026 — classified as 17 malfunctions.

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

• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT THE ATTUNE FEMUR PROBE BROKE INTO TWO PARTS WHEN BEING REMOVED FROM A STERILE TRAY DURING INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269158 ↗
• MalfunctionFeb 25, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE ANY FRAGMENTS GENERATED? YES. WERE THEY REMOVED FROM PATIENT? YES. HOW WAS THE PROCEDURE COMPLETED? YES. WAS THERE ANY SURGICAL DELAY? NO. WAS THERE ANY PATIENT CONSEQUENCES REPORTED? NO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457577 ↗
• MalfunctionJun 25, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TRIALS ALL HAVE SCRATCHES AND KNICKS OUT THE PLASTIC. HOSPITAL WILL NOT ALLOW THEM TO BE USED IN CASES. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609811 ↗
• MalfunctionJan 9, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENTS HAD SCRATCHES AND CUTS, UNABLE TO BE STERILIZED. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479843 ↗
• MalfunctionNov 27, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PAINT ON THE FEMUR TRIALS IS CHIPPING. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209666 ↗
• MalfunctionNov 22, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192093 ↗
• MalfunctionAug 16, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS ON THE ATTUNE SET BROKE AND NEED REPLACING, THEY WERE DISPOSED OF BY STERILE SERVICES. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555771 ↗
• MalfunctionApr 27, 2023Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT THE SPD DEPARTMENT FEMUR TRIALS HAVE SCRATCHES AND INDENTIONS THAT MAKE THEM IMPOSSIBLE TO CLEAN. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824442 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN DURING CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545059 ↗
• MalfunctionAug 22, 2022Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE TRIALS ARE BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266241 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED AS BROKEN 3L CR TRIAL AND IMPACTOR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935198 ↗
• MalfunctionOct 8, 2021Naturally Worn; Naturally Worn

  SEE WORD DOC FOR PRODUCT NUMBERS. IT WAS REPORTED THAT ALL OF THESE INSTRUMENTS ARE WORN OUT BEYOND SURGICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599284 ↗
• MalfunctionAug 27, 2020Material Discolored; Illegible Information; Material Discolored; Illegible Information

  IT WAS REPORTED THAT THE COLOR MARKINGS ARE WEARING OFF (12 TRIALS).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10460834 ↗
• MalfunctionAug 12, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE COLOR MARKINGS OF 12 ATTUNE FEMORAL TRIALS ARE WEARING OFF. THIS COMPLAINT CAPTURES THE 11TH AND 12TH IMPACTED PRODUCT OF (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10395800 ↗
• MalfunctionJul 23, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE COLOR MARKINGS ARE WEARING OFF.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10318292 ↗
• MalfunctionOct 9, 2018Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  MDR STAFF HAS INDICATED PRODUCTS HAVE BECOME WORN AND DISCOLOURED FROM USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948633 ↗
• MalfunctionOct 8, 2018Material Discolored; Naturally Worn; Material Discolored; Naturally Worn

  MDR STAFF HAS INDICATED PRODUCTS HAVE BECOME WORN AND DISCOLOURED FROM USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944808 ↗