ATTUNE 2545-00-998Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295135753), received between Mar 25, 2020 and Apr 26, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Recalls naming this device

1. Jun 12, 2015Class IITerminated

   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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT SURGEON BROKE MULTIPLE SZ 8 RP ARTIC SURFACE TRIALS DURING A DIFFICULT CASE. ALL BROKEN PIECES WERE REMOVED AND THE SURGERY PROGRESSED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16816016 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT SURGEON BROKE MULTIPLE SZ 8 RP ARTIC SURFACE TRIALS DURING A DIFFICULT CASE. ALL BROKEN PIECES WERE REMOVED AND THE SURGERY PROGRESSED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16816013 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT SURGEON BROKE MULTIPLE SZ 8 RP ARTIC SURFACE TRIALS DURING A DIFFICULT CASE. ALL BROKEN PIECES WERE REMOVED AND THE SURGERY PROGRESSED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16816012 ↗
• MalfunctionMay 5, 2022Crack; Crack

  IT WAS REPORTED THAT THE INSERTER AND BEARING SURFACE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286649 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR AND RP PS INSERT TRIAL WAS BROKEN DURING SURGERY. ALL PIECES WERE FOUND AND MINIMAL TIME (1 MINUTE) WAS ADDED TO SURGERY TIME.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9881093 ↗