ATTUNE 2545-00-652Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10603295133445), received between Sep 26, 2017 and Apr 20, 2026 — classified as 80 malfunctions.

The most frequently reported specific device problem is “Break” (73 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break

  CSSD ALERTED ME TO DAMAGED SHIM ON CONSIGNMENT SET - REPLACEMENT REQUIRED. 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? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931289 ↗
• MalfunctionJan 22, 2026Break; No Apparent Adverse Event

  IT WAS REPORTED DURING ROUTINE INSTRUMENT INSPECTION IT WAS DISCOVERED THAT THE INSTRUMENTS WERE WORN OR BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148044 ↗
• 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 23995837 ↗
• MalfunctionDec 12, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT SIZE 6 RP TRIAL CRACKED INTO TWO & SO DID THE 6MM SHIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794357 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A LOAN KIT INSPECTION IT WAS OBSERVED THAT THE SHIM INSTRUMENT HAD A CHIPPED EDGE. IT WAS REPORTED THAT THE EVENT WAS NOT ASSOCIATED WITH ANY SURGICAL PROCEDURE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679864 ↗
• MalfunctionNov 14, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  CHIPPED AND NOT SITTING CORRECTLY ON TIB TRAY. NO LOT NUMBERS. NO TIME ADDED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556604 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437324 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE TWO DAMAGED SHIMS. THE SHIMS ARE WORN AND NEED REPLACING, CONCERN AROUND PLASTIC FRAGMENTS COMING OFF THE SHIM. THERE WAS NO PATIENT INVOLVEMENT. SHIMS: SZ 3-4 6MM. SZ 5-6 6MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424237 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT THE SHIM TRIAL BROKE AFTER THE KNEE WAS TRIALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592652 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS. THE SPRINGS WERE WORN BECAUSE THEY ARE FREQUENTLY USED TO OPEN THE DOG BONE AND BALANCED SIZER. NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460690 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE ATTUNE SPACER SHIM SZ5/6X6MM BROKE IN HALF DURING CASE SETUP. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. ALL PARTS WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22370445 ↗
• MalfunctionMar 18, 2025Break; Scratched Material; Break; Scratched Material

  BROKEN ATTUNE SHINE 5/6 6MM. THE PLASTIC IS DAMAGED AND SCRATCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635057 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THE SHIM WAS CHIP AND THE STERILE PROCESSING DEPARTMENT (SPD) WOULD NOT ACCEPT IT. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025959 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED, THAT THE PEGS WERE BROKEN AND/OR DAMAGED WITH SPRING DAMAGE. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854508 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2024. TWO TEMPLATES BROKE IN TRAILING. SURGERY LENGTH WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824600 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT UPON TRIALING THE INSERT, THE SHIM AND TRIALING SURFACE BROKE AT THE INTERFACE. ALL PARTS WERE REMOVED FROM SURGERY THERE WAS NO HARM TO THE PATIENT OR DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493375 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED THAT THE 5/6 6MM SHIM SPRING BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088929 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE INTO TWO PIECES WHEN REMOVING AFTER TRIALING. PROPER INSTRUMENT TO REMOVE SHIM WAS NOT USED. NO PATIENT HARM, NO DELAY, ALL PIECES WERE REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977016 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A BROKEN TRIAL. SILVER RING DAMAGED AND SO MECHANISM CONNECTED TO THE SPACER BLOCK NO LONGER WORKING EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300596 ↗
• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED THAT 5-6 6MM SHIM BROKE IN HALF DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110744 ↗
• MalfunctionApr 10, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DURING A TOTAL KNEE ARTHROPLASTY, THE ARTICULARS SURFACE AND SHIMS GOT STUCK IN THE DEFINITIVE IMPLANTS AND WERE BROKEN TRYING TO REMOVE THEM. I HAVE THEM AVAILABLE FOR RETURN. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077876 ↗
• MalfunctionMar 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. VISUAL EXAM OF THE RETURNED DEVICE FOUND THAT THE DEVICE IS BROKEN IN TWO PIECES FROM HALF. IT IS ALSO OBSERVED THE DEVICE EDGES ARE CHIPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 18951668 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT SIZE 5/6 6MM SHIM WAS BROKEN INTO TWO PIECE WHEN BEING REMOVED FROM THE FIELD. THE SURGEON ACKNOWLEDGED IT, BUT IT DID NOT EXTEND SURGERY TIME AS IT WAS MOVING PAST THE TRIALING STAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807652 ↗
• MalfunctionOct 18, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE DEVICE IS CRACKED AND CHIPPED. 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. (B)(4): DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. (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 17954638 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED THAT SHIM IS BROKEN. ALL PIECES WERE RETRIEVED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777418 ↗