ATTUNE 2545-00-544Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10603295132844), received between Jun 26, 2017 and Sep 10, 2026 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Break” (51 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-2139-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 74 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 50718191 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548629 ↗
• MalfunctionJun 12, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY SURGERY FOR RIGHT KNEE OSTEOARTHRITIS. AT WOUND CLOSURE, WHEN A NURSE REMOVED THE ASSEMBLED SHIM, THE METAL SPRING RING USED TO SECURE THE SHIM IN THE SIZE #4 PSRP BECAME DISLODGED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. LOOSENING OF THE SAME SPRING RING WAS CONFIRMED IN 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490631 ↗
• 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 25152324 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE SPRING ON THE ARTICULATING SURFACE BROKE OFF. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056676 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT CENTRAL SUPPLY DISCOVERED THE ATTUNE TRAIL ARTICULATING SURFACE WAS DAMAGED. THE EVENT WAS NOT ASSOCIATED WITH ANY SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052571 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING TRIALING OF THE POLY COMPONENT, THE SPRING ON THE RIGHT SIDE OF THE ARTICULATING SURFACE BROKE. THIS DID NOT IMPACT THE SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838633 ↗
• MalfunctionDec 11, 2025Break; Break

  PLASTIC BROKE FROM ARTICULATING SURFACE WHEN REMOVING AFTER TRIAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, IP-02591909. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782221 ↗
• MalfunctionDec 4, 2025Break; Break

  TIBIAL INSERT TRIAL BROKE DURING EXTRACTION DURING TRIALLING. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? ANOTHER TRIAL WAS USED. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. DEVICE PROPERTY OF: HOSPITAL. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715002 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438920 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438881 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435865 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE WHEN THE SPECIALIST WAS GOING TO IMPACT WITH THE FEMORAL IMPACTOR, THE BLOW HE GAVE WITH THE HAMMER, THE DEVICE BROKE. IMMEDIATE SOLUTION WAS TO GIVE THE SPECIALIST ANOTHER IMPACTOR OF THE SAME CHARACTERISTICS. IN ADDITION TO THIS DURING THE PROCEDURE IT IS EVIDENT THAT THE TEST INSERTS OF 3 AND 4 REF * AND REF * DO NOT HAVE THE SPRINGS BUT OF THESE IT WAS NOT NECESSARY TO USE DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968762 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A DAMAGED ARTICULAR SURFACE TRIAL FROM THE SIZE 3-5 NOTCH GUIDES AND TRIALS CONSIGNED TRAY. THE SIZE 4 ARTICULAR SURFACE TRIAL HAS HAD IT'S SPRING BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753279 ↗
• MalfunctionOct 29, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE EVENT OCCURRED AFTER THE CASES THAT DAY. THE DEVICE BROKE IN THE REP ROOM. HOW IT BROKE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556049 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2024, THE SPRING ON THE BOTTOM OF THE ATTUNE SIZE 4 RP TRIAL CAME LOOSE. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353247 ↗
• MalfunctionSep 23, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278266 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE LEG ON THE BOTTOM OF THIS ARTICULAR SURFACE SHEETED OFF DURING USE. ALL BROKEN FRAGMENTS WERE RECOVERED. THIS DID NOT CAUSE ANY MAJOR DELAYS OR ADVERSE DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644325 ↗
• MalfunctionJun 6, 2024Crack; Crack

  IT WAS REPORTED THAT WHILE PUTTING INSTRUMENTS TOGETHER A CRACK WAS FOUND IN THE ARTICULATING SURFACE. IT WAS UNSURE WHEN THE EVENT HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476847 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ATTUNE TRIAL LINER REQUIRES REPLACEMENT BECAUSE OF MISSING BALSEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274131 ↗
• MalfunctionMay 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SHIM RING WAS DAMAGED AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237030 ↗
• MalfunctionFeb 19, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT TIB TRIAL IS BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-01960843 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01960844 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01960845 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01960846 DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729819 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT THE TWO INSTRUMENTS BROKE DURING THE CASE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445174 ↗
• MalfunctionMay 25, 2023Break; Break

  IT WAS REPORTED THAT ONE INSTRUMENT BROKE DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002703 ↗
• MalfunctionSep 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING REMOVING OF THE ATTUNE TRIAL INLAY, THE LITTLE CIRCULAR SPRING LOOSENED FROM THE UNDERSIDE OF THE INLAY AND WAS FOUND IN THE JOINT BEFORE CEMENTING THE DEFINITIVE IMPLANT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460963 ↗