ATTUNE 2545-00-974Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295135517), received between Jul 24, 2017 and Jan 9, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (29 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-2142-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY. TWO INSTRUMENTS WERE FOUND TO BE DAMAGED AFTER BEING WASHED. THE FIRST ITEM IS A SZ 4 FB ARTICULATING SURFACE, WHICH HAS A BROKEN SPRING. THE SECOND ITEM IS A 45MM ACETABULAR GRATER, WHICH HAS A CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019138 ↗
• MalfunctionMay 1, 2025Crack; Crack

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A TKA SURGERY TREATING THE KNEE. DURING THE SURGERY, THE PRODUCT IN QUESTION CRACKED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21943735 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT SPRINGS ON PRONGS WERE BROKEN. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995817 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING IS MISSING FROM THE ARTICULATION SURFACE TRIAL PATIENT STATUS/ OUTCOME / CONSEQUENCES: 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 18491756 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED THAT THE PRODUCT WAS BROKEN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265959 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT THE POLY TRIAL BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164669 ↗
• MalfunctionNov 7, 2022Crack; Crack

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE DRILL WAS DULL. THE IMPACTOR HANDLE BROKE. RED TIP BROKE OFF. ALL BEING SENT BACK. TRIAL POLY AND SHIM CRACKED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743643 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THIS ITEM WAS HELD BY THE DECONTAMINATION BECAUSE THE PRONG WAS BENT AND HAD A MISSING A SPRING. THIS WAS NOTICED AND GRAY HELD DOWN. THIS DID NOT DELAY, NO ONE WAS INJURED, AND IT IS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462876 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA WITH THE TIBIAL TRIALS IN QUESTION. AFTER INSERT TRIALS INSERTION, WHEN THE SURGEON TRIED TO REMOVE THE TIBIAL TRIALS WITH AN ELEVATORIUM, THE TIBIAL TRIALS BROKE. THE FRAGMENT WAS GENERATED, BUT IT WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THERE WAS NO FRAGMENT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725341 ↗
• MalfunctionFeb 3, 2021Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED BROKEN, WORN DOWN TRIALS AND MISSING BEARINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275631 ↗
• MalfunctionDec 29, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT SIZE 4 ARTICULATING SURFACE BROKE DURING TRIALING. SURGICAL DELAY OF 2 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 11088157 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT THE TIBIAL LEFT CUTTING BLOCK HAD A ROUGH PLACE FROM THE SAW BLADE ON THE MEDIAL SIDE OF BLOCK. THIS COULD RIP GLOVES AS IT WAS PASSED. THEY RETURNING, NO ONE WAS INJURED, SURGERY WAS NOT DELAYED. THEY HAD 2 ARTICULAR SURFACE PIECES THAT WAS BROKEN, UNFORTUNATELY THIS DID HAPPEN IN SURGERY, THEY WERE MISTAKENLY DISPOSED OF DURING WASH CYCLE, DO NOT HAD THESE TO RETURN. SURFACE PIECES RACKED IN 2 PIECES, THIS DID NOT DELAY SURGERY, NO ONE WAS INJURED AND NOT RETURNING THESE, AS THEY NEVER APPEARED AFTER WASH. THEY HAD PICTURES OF EACH ITEM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020844 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT THE TIBIAL LEFT CUTTING BLOCK HAD A ROUGH PLACE FROM THE SAW BLADE ON THE MEDIAL SIDE OF BLOCK. THIS COULD RIP GLOVES AS IT WAS PASSED. THEY RETURNING, NO ONE WAS INJURED, SURGERY WAS NOT DELAYED. THEY HAD 2 ARTICULAR SURFACE PIECES THAT WAS BROKEN, UNFORTUNATELY THIS DID HAPPEN IN SURGERY, THEY WERE MISTAKENLY DISPOSED OF DURING WASH CYCLE, DO NOT HAD THESE TO RETURN. SURFACE PIECES RACKED IN 2 PIECES, THIS DID NOT DELAY SURGERY, NO ONE WAS INJURED AND NOT RETURNING THESE, AS THEY NEVER APPEARED AFTER WASH. THEY HAD PICTURES OF EACH ITEM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020841 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT THE ARTICULATING SURFACE WAS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10845102 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT ATTUNE SPACER BLOCK CHIPPED ON THE END WHERE SPRINGS ARE, 5/6 (7MM) SHIM BROKE IN HALF, AND SIZE 4 FB ARTICULATING SURFACE CRACKED IN HALF. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10081117 ↗
• MalfunctionJan 28, 2020Break; Crack; Material Deformation; Break; Crack; Material Deformation

  IT WAS REPORTED THAT 2 ITEMS FROM CENTRAL STERILE ARE FOR REPLACEMENT. 1ST IS A FEM TRIAL, THIS TRIAL IS CRACKED ON BACK UNDER PRODUCT CODE. 2ND IS A ARTIC SURFACE FB SIZE 4, THIS PIECE HAS A BROKEN SPRING. THESE ITEMS WERE NOT USED, NEITHER OF THESE ITEMS CAUSED A DELAY, AND NOBODY WAS INJURED. I AM RETURNING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637648 ↗
• MalfunctionOct 3, 2019Break; Break

  IT WAS REPORTED THAT THE INSERT PIECE WAS BROKEN IN HALF. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152539 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT THE ATTUNE SIZE 4 FB ARTIC SURF WAS BROKEN INTO 2 PIECES UPON REMOVAL FROM PATIENT. THE BACK RIGHT SIDE WAS THE AFFECTED PORTION. BOTH PIECES WERE REMOVED FROM THE STERILE FIELD, HAVING NO AFFECT ON THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9118971 ↗
• MalfunctionSep 11, 2019Break; Break

  IT WAS REPORTED THAT THE ATTUNE SIZE 4 FB ARTICULATING SURFACE WAS BROKEN ON THE EDGE WHEN SURGEON REMOVED THE TRIAL. NO PATIENT INVOLVEMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8998302 ↗
• MalfunctionMay 7, 2019Break; Break

  IT WAS REPORTED THAT THE ARTIC SURFACE PIECE WAS BROKEN WHILE ATTACHING SHIM. PIECE WAS RECOVERED. WAS NOT IMPLANTED INTO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587829 ↗
• MalfunctionApr 25, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE UPPER AND LOWER SHIMS WERE SEPARATED WHEN THE SURGEON EXPLANTED THE TRIAL INSERT (P/N: (B)(4)) DURING TKA SURGERY ON (B)(6) 2019, AND THE RING CAME OFF AND REMAINED IN THE PATIENT'S BODY. THE SURGEON RETRIEVED THE RING FROM THE PATIENT AND COMPLETED THE SURGERY WITHIN A 30 MINUTES DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. IT WAS REQUESTED TO IMPROVE SUCH AS INTEGRATED INSERT TRIAL CREATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 8552319 ↗
• InjuryMar 28, 2019Break; Break

  IT WAS REPORTED THAT THE SZ 4 ATTUNE SHIM BROKE IN TWO PIECES. ALL PIECES WERE ACCOUNTED FOR. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461093 ↗
• MalfunctionMar 14, 2019Break; Crack; Peeled/Delaminated; Break; Crack; Peeled/Delaminated

  UPON ROUTINE INSPECTION IN SPD IT WAS NOTED THAT TWO OF THE SIZE 4 ARTICULATING SHIMS WERE CRACKED. THE BALLSEAL SPRINGS ARE STILL IN TACT AND THIS ISSUE WAS NOT NOTICED IN SURGERY. NO ADVERSE EFFECTS WERE REPORTED. ENGINEERING EVALUATION: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED CRACK. THE TRIAL WAS FRACTURED DIAGONALLY ACROSS ONE CONDYLE RUNNING ADJACENT TO THE LARGER BALSEAL. A CHIP WAS BROKEN OFF AND MISSING WHERE THE CRACK MEETS THE EDGE OF THE TRIAL. NO DAMAGES TO THE BALSEALS THEMSELVES WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422088 ↗
• MalfunctionNov 9, 2018Break; Break

  IT WAS NOTED THAT THE SIZE 4 FB ARTICULAR SURFACE BROKE DURING TRIALING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055806 ↗
• MalfunctionNov 9, 2018Break; Break

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055141 ↗