ATTUNE 2545-00-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295130468), received between Aug 10, 2021 and Oct 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT THE NOTCH GUIDE WAS BROKEN AND TAKEN OUT OF SERVICE. DID THE EVENT OCCUR DURING STERILE PROCESSING? --> NO, DID THE EVENT OCCUR DURING FIELD INSPECTION? --> NO, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940046 ↗
• MalfunctionJul 14, 2022Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT THE PATIENT WAS HAVING AN ATTUNE PRIMARY TOTAL KNEE WERE CUTTING BOX P/S FOR SIZE 9 MACRO FEMUR. WHITE 9 NUMBER FELL OFF CUT BLOCK AND WAS IMMEDIATELY RETRIEVED FROM PATIENT'S SURGICAL SITE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014171 ↗
• MalfunctionAug 10, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE MARKINGS ON THE ATTUNE INSTRUMENTS WERE FOUND DAMAGED DURING CLEANING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301906 ↗