ATTUNE 2545-00-703Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295133759), received between Sep 11, 2018 and May 18, 2026 — classified as 17 malfunctions.

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

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY A SIZE 8 CRUCIATE-RETAINING TRIAL BROKE DURING TRIALING. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25205971 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL SNAPPED IN HALF WHEN BEING IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687964 ↗
• 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 18479725 ↗
• 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 18209689 ↗
• MalfunctionNov 22, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192092 ↗
• MalfunctionNov 14, 2023Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED FROM SALES REP STATED THAT THE TRIAL WAS WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132116 ↗
• 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 16824539 ↗
• MalfunctionMar 31, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE IMPACTORS AND FEMORAL TRIALS ARE CRACKED/CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657430 ↗
• 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 15266238 ↗
• MalfunctionOct 8, 2021Naturally Worn; Naturally Worn

  SEE ATTACHED 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 12599199 ↗
• 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 10460844 ↗
• MalfunctionAug 12, 2020Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE COLOR MARKINGS OF 12 ATTUNE FEMORAL TRIALS ARE WEARING OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10397020 ↗
• MalfunctionJul 24, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information

  IT WAS REPORTED THAT THE COLOR MARKINGS ARE WEARING OFF.

  Patient problems: Not Applicable

  MAUDE report 10322203 ↗
• MalfunctionJul 13, 2020Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  WORN PRODUCT REPORTED BY STERILE SERVICES. EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10265513 ↗
• 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 7947887 ↗
• MalfunctionOct 8, 2018Naturally Worn; Optical Discoloration; Naturally Worn; Optical Discoloration

  STAFF HAS INDICATED PRODUCTS HAVE BECOME WORN AND DISCOLORED FROM USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944503 ↗
• MalfunctionSep 11, 2018Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866549 ↗