ATTUNE 2545-00-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10603295132479), received between Aug 4, 2017 and Mar 4, 2026 — classified as 102 malfunctions.

The most frequently reported specific device problem is “Break” (67 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-2137-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT LOOKING THROUGH THE TRAY AND BOTH SPRINGS WERE MISSING OFF OF THE POST. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511431 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  SPRING WENT OFF DURING THE SURGERY WHILE THE SURGEON TRIALLING. BUT NO PATIENT AFFECTED, JUST SOME DELAY AS THEY OPENED ANOTHER TRAY, THE TRAY HAD BEEN SENT TO QUARANTINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272076 ↗
• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENT WAS MISSING A SPRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617901 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIBIAL TRIALS AND SPACER BLOCKS FROM THE DEPUY ATTUNE KNEE REPLACEMENT SYSTEM INCLUDE TWO SMALL METAL SPRINGS AT THE BASE OF THE TRIAL. WE HAVE IDENTIFIED THAT, ON OCCASIONS, THESE SPRINGS CAN BECOME LOOSE AND DISLODGE FROM THE DEVICE. DURING A TOTAL KNEE REPLACEMENT SURGERY, ONE OF THE SPRINGS FROM THE ATTUNE ARTICULATING SURFACE DEVICE BECAME DISLODGED INADVERTENTLY AND COULD NOT BE LOCATED. AN X-RAY WAS PERFORMED TO ENSURE THAT THE SPRING WAS NOT INSIDE THE PATIENT FOLLOWING OUR POLICY. THE ISSUE WAS FORMALLY REPORTED TO DEPUY SYNTHES. SPRINGS FROM THE TIBIAL TRIALS AND SPACER BLOCKS ARE ALWAYS COUNTED BEFORE AND AFTER EACH SURGERY AND DOCUMENTED AS PART OF THE SURGICAL COUNT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597711 ↗
• MalfunctionAug 5, 2025Break; Break

  DURING A PROCEDURE, THE DOCTOR WAS PERFORMING FINAL TESTS FOR CONFIRMATION OF DEFINITIVE PROSTHESIS. WHEN REMOVING THE INSERT WITH THE PIECE FOR EXTRACTION, IT BROKE. THE EVENT DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719231 ↗
• MalfunctionAug 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING HAS BUCKLED AFTER BEING STERILISED. THERE WERE NO DELAYS FOR SURGERY, NOTHING WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701292 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SIZE 7 ARTICULATING SURFACE SPRINGS WERE DISSOCIATED FROM THE PEGS. THE SURGICAL DELAY IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22021903 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT INSERT BROKE WHILE TRIALING.

  Patient problems: Insufficient Information

  MAUDE report 21756650 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE INTO TWO PIECES WHILE TRIALING. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21524667 ↗
• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE, WHEN PASSING THE TEST INSERTS 7 REF, IT IS EVIDENT THAT THE TWO THAT WERE PASSED HAVE THEIR SPRINGS DAMAGED BECAUSE AT THE TIME THE INSERTS WERE MOUNTED, THE HEIGHT WAS LOOSE. IT WAS POSSIBLE TO WORK WITH THESE BUT NOT IN THE PROPER WAY DUE TO THEIR MALFUNCTION, THUS ACHIEVING SUCCESSFUL COMPLETION OF THE SURGERY, WITHOUT DISCOMFORT OF THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461349 ↗
• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE, WHEN PASSING THE TEST INSERTS 7 REF, IT IS EVIDENT THAT THE TWO THAT WERE PASSED HAVE THEIR SPRINGS DAMAGED BECAUSE AT THE TIME THE INSERTS WERE MOUNTED, THE HEIGHT WAS LOOSE. IT WAS POSSIBLE TO WORK WITH THESE BUT NOT IN THE PROPER WAY DUE TO THEIR MALFUNCTION, THUS ACHIEVING SUCCESSFUL COMPLETION OF THE SURGERY, WITHOUT DISCOMFORT OF THE SPECIALIST, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461134 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT THE ARTICULAR SURFACE WAS FOUND BROKEN BEFORE CASE. DIDN'T EFFECT PATIENT OR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117853 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE SPRING ON THE PS ARTICULATING SURFACES BROKE. THE BROKEN SPRING WAS RETRIEVED IN ONE PIECE. THE OTHER ARTICULATING SURFACE ON THE SET WAS USED. THERE WAS NO PATIENT CONSEQUENCE AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570118 ↗
• MalfunctionAug 13, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? - NO B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, DULL, WORN OR CROSS THREADED? - YES, TWO PIECES C. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? - NO D. WAS THERE ANY PATIENT CONSEQUENCES OR NOT? IF YES, PLEASE PROVIDE DETAILS. - NO E. AS THE ADDITIONAL INFORMATION RECEIVED STATES THAT "WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? NO". PLEASE VERIFY IF THIS WAS MARKED BY MISTAKE OR IF THE INSTRUMENT BROKE INTO TWO OR MORE PIECES AND WAS LEFT IN THE PATIENT? - THIS WAS MARKED BY MISTAKE. ALL PIECES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971188 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN TRIAL INSERT WAS BEING EXTRACTED FROM THE TRAILING, SCRUB NURSE NOTICE A SPRING WAS MISSING AND FOUND IT ON THE KIDNEY DISH FROM WHERE THE SURGEON PUT THEM AFTER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810602 ↗
• MalfunctionMay 19, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THERE WAS NO PATIENT HARM OR SURGICAL DELAYS. IT WAS ALSO CONFIRMED THAT THE DEVICE WAS BROKEN INTO 2 OR MORE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348609 ↗
• MalfunctionApr 5, 2024Break; Break

  IT WAS REPORTED THAT SURFACE BROKE DURING TRIALING. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050719 ↗
• MalfunctionMar 13, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: 1. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT DULL, BENT, CRACKED, STRIPPED, SCRATCHED, WORN, SCRATCHED, CROSS THREADED OR ANY DEVICE INTERACTION ISSUES? NO TABS ON BOTTOM BROKE OFF OF ONE SIDE. 2. PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY? IF YES, WAS THERE SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? YES. . 3. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893365 ↗
• MalfunctionMar 13, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: 1. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT DULL, BENT, CRACKED, STRIPPED, SCRATCHED, WORN, SCRATCHED, CROSS THREADED OR ANY DEVICE INTERACTION ISSUES? NO TABS ON BOTTOM BROKE OFF OF ONE SIDE. 2. PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY? IF YES, WAS THERE SURGICAL DELAY? WHAT WAS THE DURATION OF THE DELAY? YES. 3. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893340 ↗
• MalfunctionFeb 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  INSTRUMENTS WERE REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY. VISUAL EXAM OF THE RETURNED DEVICE FOUND IT TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664163 ↗
• MalfunctionJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE SPRING IS MISSING FROM ARTIC SURFACE. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO DID THE EVENT HAPPEN DURING A PROCEDURE? YES WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO EVENT OUTCOME/HOW WAS IT MANAGED? NO DISRUPTION TO SURGERY TIME. NOTICE AFTER IMPLANTING WHEN SEPARATED THE SHIM AND ARTICULATING SURFACE. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO DELAY TO OPERATING TIME AND NO UNTOWARD EFFECT TO PATIENT HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO IS THE PRODUCT AVAILABLE FOR RETURN? NO, (PHOTO OF ITEM SENT, SEE ATTACHED FILE) PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT. NOTICED THE MISSING SPRING ON THE ARTICULATING SURFACE ONLY AFTER IMPLANTING AND SEPARATING THE SHIM FROM THE ARTICULATING SURFACE. (SEE PHOTO)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594909 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS NOTICED THAT INSTRUMENTS ARE BROKEN UPON INSPECTION. IMPACTORS BROKEN/CRACKED PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356326 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED BY THE STAFF THAT THE INSERT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317570 ↗
• MalfunctionOct 17, 2023Break; Break

  THE ARTICULAR SURFACE WAS FOUND TO BE BROKEN WHEN THE STAFF WAS OPENING THE ATTUNE INSTRUMENTS BEFORE THE PROCEDURE STARTED. A NEW SET WAS OPENED AND USED WITHOUT ANY ISSUES OR DELAYS. THIS WAS ALL DONE BEFORE THE PATIENT WAS BROUGHT INTO THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949063 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT THE ARTICULATING SURFACE LOCKING MECHANISM BROKE IN SHIM. ALL PIECES WERE RECOVERED AND SURGERY WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 17509922 ↗