ATTUNE 2545-01-965Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295423379), received between Dec 6, 2017 and Apr 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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-2146-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT TWO SIZE 5 FIXED BEARING ARTICULAR SURFACE TRAILS WERE BROKEN ON AN UNKNOWN DATE. IT WAS UNKNOWN IF THERE WAS ANY DELAY IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21925367 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT TWO SIZE 5 FIXED BEARING ARTICULAR SURFACE TRAILS WERE BROKEN ON AN UNKNOWN DATE. IT WAS UNKNOWN IF THERE WAS ANY DELAY IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21925328 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  EACH INSTRUMENT IS COMPOSED OF 1 PART. THE SPRINGS OF EACH INSTRUMENT ARE TANGLED OR NON-UNIFORM. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841432 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS BROKE. ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619927 ↗
• MalfunctionJan 2, 2020Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SPRING OF THE INSERT TRIAL (P/N: 254501965 AND 254500652) WAS BROKEN VIA THE TKA FOR RIGHT OA. AFTER FEMORAL AND TIBIAL IMPLANTS WERE INSERTED, THE SURGEON FIXED WITH THE INSERT TRIAL TO APPLY PRESSURE IN EXTENSION POSITION. WHEN THE SURGEON TRIED TO REMOVE THE INSERT TRIAL TO INSERT AN INSERT (NOT TRIAL), HE COULD NOT REMOVE THE INSERT TRIAL FROM A TIBIAL TRAY. THE SURGEON MANAGED TO REMOVE THE INSERT TRIAL WITH A PLIERS, AND HE FOUND THAT THE SPRING OF THE INSERT TRIAL HAD BEEN BROKEN. BECAUSE THE SURGEON CONFIRMED THAT THERE WAS NO FRAGMENT IN THE PATIENT BODY, THE SURGERY WAS CONTINUED, AND IT WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 9540450 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT THE INSERT BROKE DURING THE CASE. ALL PARTS WERE RETRIEVED AND CASE WASN'T DELAYED. BROKEN ITEM BEING SHIPPED BACK TO OFFICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480373 ↗
• MalfunctionDec 6, 2017Component Missing; Component Missing

  IT WAS REPORTED THAT WHILE SETTING UP THE CASE, THE ATTUNE SPACER BLOCK AND INSERT TRIAL WERE NOTED TO HAVE BALSEALS MISSING. THE INSTRUMENTS WERE REMOVED FROM THE CASE AND REPLACED WITH AN INTACT SPACER BLOCK AND INSERT TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089689 ↗