ATTUNE 2545-00-651Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10603295133438), received between Oct 13, 2017 and Jul 28, 2026 — classified as 159 malfunctions.

The most frequently reported specific device problem is “Break” (143 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that during this case, while trailing, both size 7 PS RP trials, the size 5/6 5mm and the size 7/8 5mm shims all broke. There was no harm to patient or delay and all pieces of the broken trial were found.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063168 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT THE SHIM DEVICES WERE BROKEN, THE ALIGNMENT ROD WAS BENT AND THE TRIAL POST DEVICES WERE CRACKED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. THERE WAS NO PATIENT OR USER HARM. THERE WERE NO REPORTS OF SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351293 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT THERE WERE BROKEN TRIAL SHIMS, BENT ALIGNMENT ROD, CRACKED TRIAL POST.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096177 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT A BIT OF PLASTIC BROKE OFF FROM THE SHIM TRIALS. THERE WERE NO DELAYS, AND NOTHING WAS LEFT IN THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844423 ↗
• MalfunctionMar 18, 2026Device-Device Incompatibility

  IT WAS REPORTED PART WOULD NO LONGER FIT IN THE ADAPTOR. DEVICE WAS FOUND IN WASH THAT WAY. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629056 ↗
• MalfunctionFeb 13, 2026Break; Scratched Material

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN, THE ATTUNE SHIM SZ5 5MM HAD MULTIPLE GOUGES AND DEEP SCRATCHES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332556 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT SHIM BROKE AS DOCTOR WAS REMOVING THE TRIAL. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261764 ↗
• MalfunctionDec 3, 2025Break; Break

  SHIM BROKE IN TWO. ALL BITS RETRIEVED. NO TIME ADDED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703635 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS BROKEN DURING TRIAL REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622010 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT ATTUNE SHIM BROKE WHILE REMOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572706 ↗
• MalfunctionNov 13, 2025Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO ATTUNE SHIM DEVICES WERE BROKEN IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544676 ↗
• MalfunctionOct 31, 2025Break; Crack; Break; Crack

  MEDICAL DEVICE REPROCESSING CANNOT RE-STERILIZE THE ATTUNE SHIMS, FEMORAL TRIALS AND IMPACTORS IN THE SETS DUE TO THEM HAVING MULTIPLE CHIPS AND MICRO CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437574 ↗
• MalfunctionOct 28, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, MEDICAL DEVICE REPROCESSING STATED THAT THEY CANNOT RE-STERILIZE THE ATTUNE SHIMS, FEMORAL TRIALS AND IMPACTORS IN THE SETS DUE TO THEM HAVING MULTIPLE CHIPS AND MICRO CRACKS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401319 ↗
• MalfunctionOct 1, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY WITH THE ATTUNE SYSTEM AND WHEN USING THE ATTUNE KNEE TEST INSERTS, IT WAS DETECTED THAT ONE OF THE SPRINGS FELL OFF AND REMAINED INSIDE THE KNEE. IT COULD BE REMOVED WITHOUT LEAVING ANY REMAINS ON THE PATIENT. HOWEVER, THIS FACT IS A VERY SERIOUS SITUATION, SINCE IT COMPROMISES THE INTRAOPERATIVE SAFETY AND THE RELIABILITY OF THE INSTRUMENTS. IT ALSO GENERATES INSECURITY REGARDING THE SIZE OF THE TEST INSERT AND CAN MODIFY THE HEIGHT OF THE LINERS ALTERING THE RELIABILITY OF THE INSTRUMENT AND THUS OPEN A WRONG DEFINITIVE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190706 ↗
• 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 22460731 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPACER SHIM CRACKED INTO TWO PIECES DURING SURGERY. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460678 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457378 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL PEG BROKE OFF WHEN DISCONNECTING FROM THE SHIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327015 ↗
• MalfunctionJun 10, 2025Crack; Crack

  IT WAS REPORTED THE INSTRUMENTS WERE CRACKED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178149 ↗
• MalfunctionMay 8, 2025Break; Break

  THE PS FEM TRIAL CRACKED FROM THE BACK, TIBIAL IMPACTOR CRACKED IN HALF AND THE SHIM GOT CHIPPED. THE PRODUCT DAMAGE DOCUMENTED WAS IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986149 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT ARTIC SURF 6RP HAS A DAMAGED PEG ON THE BOTTOM, LEFT SURFACE. THERE ARE NO PIECES DISLODGED FROM THE INSTRUMENT. SURGERY TIME WAS NOT EXTENDED AND NO AFFECT TO THE PATIENT. SIZE 5-6 5MM SHIM BROKE INTO 2 PIECES. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD AND SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950900 ↗
• MalfunctionApr 22, 2025Break; Break

  THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883193 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856637 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE PROSTHESIS ON (B)(6) 2025. DURING THE PROCEDURE, AN INSERT PLATE SIZE 5 BROKE AT THE END OF THE TESTS. THE DEVICE HAS BEEN IN CONTACT WITH THE PATIENT. THERE WAS NO CONSEQUENCE TO PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751610 ↗
• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE IN SURGERY WHILE TRIALING.

  Patient problems: Insufficient Information

  MAUDE report 21576765 ↗