ATTUNE 2545-00-995Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295135722), received between Jul 6, 2017 and Jan 2, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Jun 12, 2015Terminated

   Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

   Z-2143-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT THE DOCTOR BROKE THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949802 ↗
• MalfunctionMar 20, 2024Break; Break

  BROKEN/ DAMAGED INSTRUMENTS AT HOSPITAL NEEDING REPLACEMENTS. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941932 ↗
• MalfunctionFeb 23, 2024Break; Break

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. THIS EVENT DIDN'T HAPPEN IN SURGERY. IT WAS REPORTED THAT THE TRIALS ARE CHIPPED WHERE THE INSERT HANDLE ATTACHES. THIS WAS DISCOVERED WHEN INSPECTING THE TRAYS BEFORE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766327 ↗
• MalfunctionFeb 23, 2024Break; Break

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. THIS EVENT DIDN'T HAPPEN IN SURGERY. IT WAS REPORTED THAT THE TRIALS ARE CHIPPED WHERE THE INSERT HANDLE ATTACHES. THIS WAS DISCOVERED WHEN INSPECTING THE TRAYS BEFORE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766323 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT ARTICULATE SURFACE BROKE DURING TRIALING. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381614 ↗
• MalfunctionMar 24, 2020Break; Material Deformation; Material Twisted/Bent; Scratched Material; Break; Material Deformation; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT THE PHOTOGRAPHS OF THE 254500995 ATTUNE CONV RP PS TB TRL SZ5 SHOWING SOME DAMAGED TO ONE EDGE AND INDENTED MARKS ON THE TRIAL FACE. THE ASSESSMENT OF THE INSTRUMENT IS WEAR AND TEAR. THE ITEM WILL BE DISPOSED OF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9871127 ↗
• MalfunctionJan 25, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING WASHING THE ARTICULATING SURFACES CAME OUT BROKEN AND THE SPRING WAS DISLODGED. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8277290 ↗
• MalfunctionOct 25, 2018Break; Break

  THE POLY TRIALS AND SHIM WERE BROKEN WHILE TRYING TO INSERT INTO THE PATIENT WHEN TRIALING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006521 ↗
• MalfunctionJul 27, 2018Component Missing; Component Missing

  THESE ITEMS WERE REPORTED BY (B)(6) CSD STAFF. NOT RELATED TO AN OPERATIVE CASE. ATTUNE LINER TRIAL IS MISSING AN O-RING SPRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726625 ↗
• MalfunctionJul 19, 2018Break; Break

  ATTUNE TOTAL KNEE REPLACEMENT. (B)(6): (B)(6) HOSPITAL, (B)(6) 2018. THE SPRING ON THE SIZE 5 ATTUNE PS RP INSERT TRIAL BROKE DURING REMOVAL OF THE INSTRUMENT FOLLOWING A TRIAL REDUCTION. ALL AFFECTED PARTS WERE ACCOUNTED FOR, AND THE BROKEN SPRING WAS DISCARDED BY THE SCRUB NURSE. INSTRUMENT WAS NO LONGER NEEDED, SO OPERATION CONTINUED AS NORMAL. NO AE TO PATIENT. NO DELAY TO THE PROCEDURE. PATIENT INITIAL (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7703407 ↗
• MalfunctionJul 6, 2017Break; Break

  IT WAS REPORTED THAT DURING THE CASE THE SPRING POPPED OFF BOTTOM OF THE RP INSERT TRIAL ARTICULATING SURFACE SIZE 5.

  Patient problems: No Information

  MAUDE report 6692042 ↗