ATTUNE 2545-01-964Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295423362), received between Sep 15, 2017 and Nov 8, 2021 — classified as 4 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 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Break; Break

  IT WAS REPORTED THAT THEY BROKE BOTH PINNACLE CUP INSERTS WHILE IMPLANTING PINNACLE CUP. THEN, ON KNEE SURGERY, WE BROKE POLY TRIAL WILE EXTRACTING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12769280 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL BROKE WHEN THE SURGEON HIT IT WITH A MALLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772700 ↗
• MalfunctionMar 23, 2018Break; Break

  THE REPORTED DEVICE WAS USED FOR ANOTHER TKA SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE SPRING OF THE STOPPER OF THE DEVICE WAS BROKEN DURING THE CLEANING AT THE PREPARATION OF THE SURGERY. THE SURGERY WAS COMPLETED ALTHOUGH THE BROKEN DEVICE WAS NOT IN USE FOR THE SURGERY. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367388 ↗
• MalfunctionSep 15, 2017Break; Break

  IT WAS REPORTED THAT THE ATTUNE FB CR ART SURF SZ4 CONV BROKE DURING TRIALING OF KNEE.

  Patient problems: No Information

  MAUDE report 6867914 ↗