ATTUNE 2545-00-744Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295134169), received between Jun 22, 2017 and Oct 27, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE TRIAL POLY, THE 7RP ARTIC SURF BROKE ON THE BOTTOM OF THE INSTRUMENT. A SMALL PIECE BROKE OFF AND WAS REMOVED FROM THE STERILE FIELD. THE 7MM SIZE 7-8 SHIM ALSO BROKE INTO 2 PIECES DOWN THE MIDDLE. BOTH PIECES WERE REMOVED FROM THE STERILE FIELD. SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391411 ↗
• MalfunctionAug 18, 2025Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED THAT SHIMS WERE CRACKED AND DAMAGED. 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 22833176 ↗
• MalfunctionJul 10, 2025Crack; Crack

  IT WAS REPORTED THAT ATTUNE INSERT TRIAL EXTRACTOR AND 7MM SHIM CRACKED DURING INSERT TRIAL EXTRACTION. THERE WAS NO SURGICAL DELAY OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472338 ↗
• MalfunctionOct 23, 2023Break; Break

  IT WAS REPORTED THAT WHILE REMOVING ALL TRIALS FROM THE PATIENT, AND PREPARING TO OPENING IMPLANTS THE SHIM WAS BROKEN INTO TWO PIECES RIGHT IN HALF. BOTH PIECES WERE RECOVERED FROM THE FIELD AND THIS DID NOT EXTEND SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985365 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT WHILE REMOVING ALL TRIALS FROM THE PATIENT, AND PREPARING TO OPENING IMPLANTS THE SHIM WAS BROKEN INTO TWO PIECES RIGHT IN HALF. BOTH PIECES WERE RECOVERED FROM THE FIELD AND THIS DID NOT EXTEND SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977035 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED THAT SMALL PIECES BROKE OFF THE SHIM DURING CLEANING PROCESS. SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798188 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT THE 7/8 7MM SHIM WAS BROKEN BY THE SURGEON DURING THE CASE. ALL BROKEN PIECES WERE RETRIEVED. THERE WAS NO EFFECT ON THE CASE OUTCOME. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685610 ↗
• MalfunctionAug 22, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENT HAD CHIPS AND SCRATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597895 ↗
• MalfunctionMar 28, 2023Break; Break

  IT WAS REPORTED THAT WHILE SURGEON WAS BRINGING KNEE FROM FLEXION TO EXTENSION TRIALING FEMORAL COMPONENT, TIBIA AND INSERT (SIZE 8 AND 7MM) AND THE SHIM AND ARTICULATING SURFACE BROKE AS HE WAS MOVING THE LEG/KNEE INTO EXTENSION. USED A SIZE 6MM AND IT WAS GOOD. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627443 ↗
• MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ITEMS WERE INSPECTED BY STAFF AND DEEMED DAMAGED, WILL NOT REPROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799215 ↗
• MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ITEMS WERE INSPECTED BY STAFF AND DEEMED DAMAGED, WILL NOT REPROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799203 ↗
• MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem

  ITEMS ARE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734186 ↗
• MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem

  ITEMS ARE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734179 ↗
• MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem

  ITEMS ARE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734111 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175242 ↗
• MalfunctionJan 5, 2022Break; Break

  FRAGMENT BROKE OFF OF THE TRIAL. THE FRAGMENT AND SHIM WERE REMOVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172594 ↗
• MalfunctionJul 28, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE ATTUNE 7MM SHIM IS BEING RETURNED AS PARTS OF IT ARE CHIPPED, SCRATCHED TO POINT WHERE SPD BROUGHT IT TO OUR ATTENTION. DATE OF OCCURRANCE WAS (B)(6) 2021, POST OP, NO DELAY TO CASE. THE 2 ACTIS STEM INSERTERS AND HANDLE ARE BEING RETURNED AS WE HAVE EXPERIENCED DIFFICULTY INSERTING THESE INSERTERS INTO VARIOUS HANDLES AND THE HANDLE HAD DIFFICULTY TAKING THE INSERTERS SO WE'RE REPLACING ALL 3. DATE OF OCCURRANCE WAS (B)(6) 2021, POST OP, NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242751 ↗
• MalfunctionMar 8, 2021Use of Device Problem; Use of Device Problem

  SPRING WASHER WAS ABSENT FROM TRIAL ARTICULAR SHIM. FOUND MISSING AFTER BEING REMOVED FROM PATIENT AND FINAL INSERT IMPLANTED, SO INSERT REMOVED TO FACILITATE SEARCH FOR WASHER AND LAVAGE WASHOUT OF JOINT. SPRING WASHER NOT FOUND IN SITU. NEW INSERT INSERTED, OLD DISCARDED. POST OP X-RAY NO SIGN OF SPRING WASHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436479 ↗
• MalfunctionOct 29, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN INSTRUMENTS IDENTIFIED BY STERILISATION, DID NOT OCCUR DURING SURGERY. INSTRUMENTS TAGGED AS DAMAGED AND BEING RETURNED TO WA OPERATIONS VIA COURIER.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10754664 ↗
• MalfunctionAug 15, 2019Break; Material Deformation; Break; Material Deformation

  VARIOUS ATTUNE SHIMS FROM THE "SHIMS AND GENERAL INSTRUMENT" TRAY ARE SHOWING SIGNS OF WEAR, IN PARTICULAR CHIPPING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897287 ↗
• MalfunctionJun 14, 2019Break; Break

  SIM BROKE UPON COMPLETION OF THE TRAILING OF THE IMPLANT AND DURING THE REMOVAL OF THE TRIAL INSERT. BROKEN SHIM WAS REMOVED AND THE SURGEON PROCEEDED TO IMPLANT DEFINITIVE IMPLANTS SO THERE WAS NO ADVERSE IMPACT ON THE PROCEDURE OR ON THE PATIENT. 30 SECONDS DELAY TO THE PROCEDURE.

  Patient problems: Not Applicable

  MAUDE report 8701272 ↗
• MalfunctionSep 25, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT ATTUNE SHIMS CHIPPED AND DAMAGED FROM RETRACTORS IN SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7908397 ↗
• MalfunctionAug 13, 2018Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE SHIMS CRACKED. REP FOUND DURING INSPECTION AND NOT DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776424 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED THAT DURING CASE, IMPACTOR WAS BROKEN AND SHIM WAS DAMAGED WITH OSTEOTOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761691 ↗
• MalfunctionJun 22, 2017Break; Break

  IT WAS REPORTED THAT THE ATTUNE SHIM BROKE DURING EXTRACTION.

  Patient problems: No Information

  MAUDE report 6661625 ↗