ATTUNE 2513-14-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295438816), received between Sep 11, 2020 and Aug 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT THE THREADS OF THE 110X14 PRESS-FIT STEM TRIAL BROKE OFF INSIDE THE 37 MM TIBIAL SLEEVE BROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784122 ↗
• InjurySep 11, 2020Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  DURING A 2ND STAGE KNEE REVISION THE SURGEON REPORTED FRACTURING THE PROXIMAL TIBIA WHEN SEATING THE ATTUNE REVISION TIBIAL BROACH IN THE PROXIMAL TIBIA. THE SURGEON HAD ALREADY PREPARED THE PROXIMAL TIBIA BONE WITH A STEM PILOT/BROACH AND TIB TRAY HOWEVER WHEN HE EXTRACTED THE TRIAL CONSTRUCT (WITH RP ADAPTER AND SYSTEM HANDLE) THE TIB TRAY ROTATION WAS NOT LOCKED AND THEREFORE HE WAS REQUIRED TO RE-SEAT THE STEM TRIAL/BROACH INTO THE PREPARED BONE ENVELOPE AND LOCK OFF HIS RP TRAY ROTATION BEFORE EXTRACTING AND TRANSFERRING THIS TO THE DEFINITIVE IMPLANT/ASSEMBLING. HE COMMENTED THAT WHEN THE REGISTRAR RE-INSERTED THE BROACH INTO THE BONE SHE HIT IT TOO HARD WHICH HE THINKS CAUSED THE FRACTURE. IT WAS WORTH NOTING THAT THE REGISTRAR ALSO HAD GREAT DIFFICULTY EXTRACTING THE TRIAL STEM AND BROACH/TRAY CONSTRUCT ONCE THE ROTATION HAD BEEN LOCKED AND WHEN THE SURGEON TOOK OVER, HE ENDED UP REMOVING THE RP TRIAL TRAY AND ATTACHING THE BROACH HANDLE TO REMOVE THE BROACH (WHICH IS WHEN HE NOTICED THE SMALL FRACTURE IN THE PROX TIB) AND REPEATING THE ABOVE STEPS TO SET THE ROTATION. THE SURGERY CONTINUED AS PLANNED AND HE ADVISED THAT THIS FRACTURE WOULD NOT CHANGE THE OUTCOME OF THE SUR

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10521878 ↗