ATTUNE 2545-01-966Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295423386), received between Mar 29, 2019 and Feb 25, 2020 — 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-2146-2015 · 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.

• MalfunctionFeb 25, 2020Break; Break

  CUSTOMER IS COMPLAINING THE PEG TO BE BROKEN OFF THE INSTRUMENT. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT, NO PART REMAINING IN PATIENT´S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752280 ↗
• MalfunctionDec 13, 2019Break; Break

  BAL SEAL BROKE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468982 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED THAT THEY LOST A BUSINESS AT THE HOSPITAL. ALL INSTRUMENTS HAVE BEEN PULLED TO RE-ALLOCATE WITHIN THE TERRITORY. BROKEN INSTRUMENTS WERE IN A DESIGNATED BOX AT FACILITY LABELED AS "BROKEN" OR WERE FOUND IN STERILE WRAPPED PANS THAT WERE RETURNED TO OFFICE. NO PATIENT WAS AFFECTED. NO SURGERY WAS AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841393 ↗
• MalfunctionJun 20, 2019Connection Problem; Device-Device Incompatibility; Material Twisted/Bent; Connection Problem; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SPRING ON THE ATTUNE SIZE 6 FB ARTICULATING SURFACE INSTRUMENT WAS DAMAGED NOT ALLOWING THE SHIM TO ATTACH. THE ARTICULATING SURFACE WAS NOT USED IN THIS CASE AND WAS NOT ATTEMPTED TO BE USED ON THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717460 ↗
• MalfunctionMar 29, 2019Break; Break

  INSTRUMENT´S PEG BROKE OFF. NO PART REMAINING IN PATIENT, NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464683 ↗