ATTUNE 2545-00-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10603295132455), received between Jul 25, 2017 and May 12, 2026 — classified as 1 injury, 124 malfunctions.

The most frequently reported specific device problem is “Break” (85 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-2137-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT WHEN REMOVING THE POLY TRIAL, ONE OF THE CONNECTION POINTS FOR THE SHIM BROKE. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149528 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT THE ATTUNE FB PS ARTIC SURF SZ5 BROKE DURING TRIAL. NO PATIENT WAS HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033165 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  THE PRODUCT BROKE DURING THE CASE. THE SPRING CAME OFF THE ARTICULATING SURFACE. IT WAS NOT USED ON THE PATIENT. THERE WERE NO DELAYS TO A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980795 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE WASHER BROKE OFF FROM PIN HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953830 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). THE TRIAL BROKE DURING TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489652 ↗
• MalfunctionJan 7, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE THE SPRING HAS COME LOOSE AND BROKE. NO ADVERSE OUTCOME WAS REPORTED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995935 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT THE WHILE EXTENSION AND FLEXION TESTS WERE PERFORMED, IT WAS OBSERVED THAT THE COMPONENTS WERE REMOVED WHEN THE IMPLANTS ARE BROKEN. THERE WAS NO DELAY IN THE SURGERY, THE OTHER INSERT WAS TAKEN AND THE HEIGHT WAS TAKEN FROM ANOTHER SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995836 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE KNOB SECURING THE SHIM TO THE INSERT BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926402 ↗
• MalfunctionDec 4, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE SPRING BROKE INTO 2 PIECES AND IT WAS ALL RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716363 ↗
• MalfunctionNov 11, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPRING ON THE INSERT TRIAL WAS BROKEN AND WOULD NOT ATTACH TO THE SHIMS PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524252 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE DEVICE HAS LOST ITS SPRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23282792 ↗
• MalfunctionJul 31, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED SEVERAL DEVICES WERE FOUND WITH ISSUES DURING ROUTINE INSPECTION AT FIELD SALES OFFICE. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676596 ↗
• MalfunctionJul 31, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED: UNDERNEATH BUTTON BROKEN DID NOT HAPPEN I. SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676337 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT A ATTUNE FB PS ARTHRITIC SURF INSERTS SZ 5 BROKEN IN SURGERY AT THE TIME OF TEST EXTRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308955 ↗
• MalfunctionJun 13, 2025Break; Break

  IT WAS REPORTED THAT PRE-OPERATIVELY BEFORE A KNEE SURGERY, THE ITEM'S SPRING WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201356 ↗
• MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIBIA INSERTS FROM ATTUNEM5 WERE REPORTED HAVE SPRING LOOSENED BEFORE OPERATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938217 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT THE FEMORAL TRIAL WAS DROPPED ON THE FLOOR, AND THE TWO ARTICULATING SURFACES SPRINGS WERE BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21343533 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TRIAL TIBIAL INSERT BROKE WHEN IT WAS BEING REMOVED. A QUICK SOLUTION WAS FOUND USING ANOTHER TRIAL TIBIAL INSERT THAT WAS INSIDE THE TIBIAL TRAY IN THE EQUIPMENT. PROCEDURE WAS FINISHED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267305 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT THE ATTUNE FB PS ARTICULATION SURFACE BROKE INTO 2 PIECES DURING THE SURGERY. BOTH PIECES GOT EXTRACTED FROM THE PATIENT AND THEY HAVE USED OTHER SIMILAR TRIAL FROM THE SET TO DO THE TRIALING. SURGERY WAS DELAYED 1 MINUTE DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235318 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT THERE WERE 2 BROKEN EVAL BULLETS THAT NEED REPLACED, AND A BROKEN SURFACE PIECE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809683 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA WITH THE PRODUCT IN QUESTION. DURING SURGERY, AFTER THE TRIAL WAS REMOVED, IT WAS CONFIRMED THAT THE SPRING OF THE PRODUCT IN QUESTION WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19729766 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT THE TIBIAL 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? UNKNOWN. 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. (B)(4). 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 18856101 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE SPRING OF THE ARTICULATION TRIAL IS MISSING. 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 18492022 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NURSE REPORTED BROKEN INSTRUMENTS WHICH REQUIRE REPLACEMENT. ADDITIONAL EVENT INFORMATION: INSTRUMENT WAS FOUND DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2024 THAT ONE OF THE SPRING WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491448 ↗
• MalfunctionDec 4, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SPRING ON THE BOTTOM STRETCHED OUT . NOTHING WAS LEFT IN THE PATIENT. THERE WAS NO ADVERSE EFFECTS. NO TIME WAS ADDED INTO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259015 ↗