ATTUNE 2513-16-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295438861), received between Mar 6, 2020 and Jan 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break; Device-Device Incompatibility

  [SURGEON] - KNEE REVISION - [HOSPITAL] : WHILE PERFORMING TIBIAL BROACHING, THE 16 × 60 PRESS-FIT STEM TRIAL THAT HAD BEEN ATTACHED TO THE DISTAL END OF THE SIZE 37 TIBIAL BROACH SNAPPED AND REMAINED TRAPPED IN THE TIBIAL CANAL WITH NO REMAINING THREADS. THE STEM WAS FORTUNATELY RETRIEVED USING A KOCHER. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, 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.

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

  MAUDE report 23949746 ↗
• MalfunctionDec 4, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED LEFT TOTAL KNEE. THE INFECTION IS GONE, SO THE SURGEON REMOVED THE TEMPORARY SPACER AND IMPLANTED DEFINITIVE COMPONENTS. DURING BROACHING OF THE TIBIA, THE STEM TRIAL BROKE OFF THE END OF THE BROACH AND WAS STUCK IN THE TIBIAL CANAL. IT TOOK 5 MINUTES TO GET THE BROKEN TRIAL STEM OUT OF THE CANAL AND TO GET THE THREADED PIECE OUT OF THE BROACH SO THE BROACH COULD BE USED AGAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845336 ↗
• MalfunctionJun 3, 2024Break; Break

  ATTUNE REVISION PRESS FIT STEM TRIAL BROKE OFF FROM TIBIAL BROACH DURING TIBIAL BROACHING.

  Patient problems: Insufficient Information

  MAUDE report 19447406 ↗
• MalfunctionOct 19, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT TRIAL IS BROKEN. THERE WAS 20 MINUTES SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632766 ↗
• MalfunctionOct 15, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE MALE PART OF THE STEM TRIAL THAT THREADS INTO THE BROACH IS WHAT BROKE.

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

  MAUDE report 10684488 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT THE STEM TRIAL "MALE" ADAPTER SNAPPED OFF INSIDE OF THE 29 MM TIBIAL BROACH. BOTH THE STEM TRIAL AND THE BROACH WERE RETRIEVED. INCIDENT HAPPENED DURING TIBIAL BROACHING. PATIENT WAS NOT INJURED, NO DELAY IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801480 ↗