ATTUNE 2545-00-973Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295135500), received between Sep 22, 2017 and Sep 10, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (12 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, 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-2142-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724090 ↗
• MalfunctionMay 12, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON B)(6) 2026, THE PATIENT UNDERWENT TKA FOR KNEE OA ON THE RIGHT SIDE. AT WOUND CLOSURE, WHEN A NURSE REMOVED THE SHIM ASSEMBLED TO THE DEVICE, THE METAL SPRING RING USED TO SECURE THE SHIM BECAME DISLODGED (SIZE #4 PSRP). THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. LOOSENING OF THE SAME SPRING RING WAS CONFIRMED IN THE SIZE #3 PSFB AND SIZE #5 PERP INSERT TRIALS. THE SURGEON CONFIRMED BY X-RAY THAT NO BROKEN FRAGMENTS OR COMPONENTS REMAINED IN THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152327 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT THE ATTUNE CONV FB PS TB TRL SZ3 BROKE AT THE SPRING AROUND THE SURFACE FACE OFF, DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064730 ↗
• MalfunctionOct 31, 2022Crack; Crack

  IT WAS REPORTED THAT SEVERAL ITEMS HAVE CRACKS AND NEED TO BE REPLACED. IT WAS NOTIFIED BY CENTRAL STERILE, THIS DID NOT INVOLVE A SURGERY. RETURNING ALL COMPONENTS FOR INSPECTION. THIS DID NOT DELAY A SURGERY. NO ONE WAS INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700246 ↗
• MalfunctionFeb 9, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE X1 SPRING IS STRETCHED SO DOESN'T FIT THE SHIMS ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497183 ↗
• MalfunctionNov 19, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED AS "CENTRAL STERILE HAS 2 ARTIC SURF THAT ARE BROKEN, AND NEED REPLACED. 1 IS IN 2 PIECES, AM RETURNING BOTH PIECES. THE SECOND HAS A BENT PRONG AND SPRING. I AM RETURNING BOTH FOR INSPECTION. THIS DID NOT DELAY A SURGERY, NO ONE WAS INJURED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847097 ↗
• MalfunctionJan 29, 2021Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL BROKE WHILE PLACING FINAL IMPLANTS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253672 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL BROKE AFTER EXTRACTION. NO PIECES WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11123565 ↗
• MalfunctionSep 22, 2020Use of Device Problem; Component Missing; Material Deformation; Material Twisted/Bent; Use of Device Problem; Component Missing; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE CENTRAL STERILE DEPARTMENT HAS INDICATED THEY HAVE SEVERAL BROKEN DEPUY ITEMS. A SPACER BLOCK THAT ON THE EXTENSION END HAS ONE BENT/BROKEN PRONG, MISSING A SPRING, WHILE THE OTHER SIDE HAS A WARPED SPRING. A 3 FB ARTIC SURF THAT IS MISSING A SPRING ON THE PRONG, AND HAS A WARPED PRONG ON OPPOSITE SIDE. A SIZE 6 FB ARTIC SURF WITH A BENT PRONG, AND MISSING SPRING. A 8 ARTIC SURFACE THAT IS MISSING A SPRING. NONE OF THESE ITEMS CAUSED A DELAY IN ANY SURGERY. NOBODY WAS INJURED BY THESE MISSING PIECES, OR BROKEN PIECES.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10569776 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT THE SPRING OF AN ATTUNE CONV FB PS TB TRL SZ3 BROKE WHEN TRYING TO REMOVE THE TRIAL INSERT FROM FINAL COMPONENTS. ALL PARTS REMOVED FROM PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10536399 ↗
• MalfunctionSep 6, 2018Component Missing; Component Missing

  CSD REPORTED A MISSING SPRING ON THE TRIAL. PATIENT CONSEQUENCE? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850587 ↗
• MalfunctionAug 9, 2018Break; Break

  IT WAS REPORTED THAT THE ARTICULATING SURFACE CRACKED; ALL PIECES RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7767384 ↗
• MalfunctionJun 7, 2018Break; Break

  RUPTURE OF A KNEE ATTUNE IMPACTOR. PLEASE FIND PICTURE ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577553 ↗
• MalfunctionMay 23, 2018Break; Disassembly; Material Deformation; Break; Disassembly; Material Deformation

  IT WAS REPORTED THAT THE SPRING CAME OFF SIZE 3 ARTICULATING SURFACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537603 ↗
• MalfunctionDec 27, 2017Break; Break

  ARTICULATING SURFACE FB CRACKED AND BROKE AND OTHER SIZE 3 ARTICULATING SURFACE FB HAS BROKEN SPRING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7147825 ↗
• MalfunctionSep 22, 2017Break; Break

  IT WAS REPORTED THAT THE SIZE 3 PS INSERT TRIAL BROKE INTO 3 PIECES WHEN REMOVING THE TRIAL FROM THE KNEE.

  Patient problems: No Information

  MAUDE report 6886198 ↗