ATTUNE 2544-00-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 279 adverse event reports that list this exact device (DI 10603295434030), received between Jul 20, 2017 and Sep 30, 2026 — classified as 2 injuries, 277 malfunctions.

The most frequently reported specific device problem is “Break” (130 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 279 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device-Device Incompatibility

  It was reported that the distal femoral cut jig did not capture the cut block as it should have. There was no reported patient or user harm. There was no significant delay. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947279 ↗
• MalfunctionSep 21, 2026Break; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845962 ↗
• MalfunctionJul 1, 2026Material Deformation

  IT WAS REPORTED THAT SPRING IS LOOSE. THERE WAS NO DELAY AND NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682510 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE JIG OF THE DISTAL FEMUR CUTTING GUIDE HAD A WEAK SPRING. THE WEAKNESS WAS IDENTIFIED DURING SURGERY BECAUSE THE CUTTING BLOCK FELL OFF EASILY WHEN BEING ADAPTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490169 ↗
• MalfunctionMay 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY A PART OF THE ATTUNE DISTAL FEMORAL JIG DID NOT REMAIN CLIPPED TO THE DISTAL CUT BLOCK. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243489 ↗
• MalfunctionApr 20, 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 24926546 ↗
• MalfunctionApr 9, 2026Break

  IT WAS OBSERVED BY CENTRAL SUPPLY THAT THE DISTAL FEMORAL JIG WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831296 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT A PIN LODGED INSIDE ONE OF THE PIN HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829573 ↗
• MalfunctionMar 17, 2026Material Integrity Problem

  IT WAS REPORTED THE DEVICES WERE DAMAGED. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616733 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT RED CLIP BROKE WHEN REMOVING IT. THERE WERE NO DELAYS OR INJURIES RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366278 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RED CLIP WAS BROKEN WHEN REMOVING IT. IT WAS REPORTED THAT THERE WERE NO DELAYS NOR ANY INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344355 ↗
• MalfunctionFeb 5, 2026Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. THE PRODUCT WAS USED ON FRIDAY, (B)(6) 2025 2:00 PM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON FRIDAY AT 6:00 PM WHILE SORTING INSTRUMENTS FOR THE NEXT OPERATION (MONDAY, (B)(6) 2025, A WIRE-LIKE PART ON THE OUTRIGGER SLIDE WAS FOUND TO BE PROTRUDING OUTWARD, DESPITE ITS INHERENT DESIGN NOT BEING EXPOSED. THIS PROTRUSION IS NOT SEEN ON NORMAL PRODUCTS. THIS PRODUCT WAS NOT USED DURING THE OPERATION ON MONDAY, (B)(6) 2025, AND THE SAME PRODUCT AT ANOTHER FACILITY WAS USED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268995 ↗
• MalfunctionFeb 3, 2026Structural Problem

  IT WAS REPORTED THAT THE FEMORAL JIG RESECTION KNOB¿S SETTING CHANGED ON THE UNKNOWN ALIGNMENT DEVICE WHILE THE SURGEON WAS PREPARING TO MAKE THE FIRST CUT. THE DEVICE FLIPPED UPSIDE DOWN WHEN PICKED UP AND, AFTER BEING RETURNED, THE RESECTION SETTING WAS CHANGED. THE SURGEON DETECTED THE INCORRECT SETTING BEFORE CUTTING AND RESTORED IT TO THE CORRECT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247550 ↗
• InjuryFeb 3, 2026Improper or Incorrect Procedure or Method; Structural Problem

  IT WAS REPORTED THAT THE UNK ALIGNMENT DEVICE EXPERIENCED A FAILURE DURING A SURGICAL PROCEDURE. THE DEVICE'S DISTAL FEMORAL JIG, INTENDED FOR A 9MM FEMORAL RESECTION, WAS INCORRECTLY ASSEMBLED BY THE SCRUB NURSE, RESULTING IN THE SURGEON PERFORMING A DISTAL FEMORAL CUT THAT WAS OVER-RESECTED. THE LOCKING FEATURE OF THE DEVICE DID NOT FUNCTION AS INTENDED, AND THE SETTINGS FAILED TO STAY LOCKED IN PLACE. THIS LED TO A PROLONGED SURGERY AND BONE INJURY, REQUIRING THE SURGEON TO RE-ATTACH THE RESECTED BONE AS A BONE AUGMENT, WHICH CONSTITUTED A SERIOUS INJURY AND NECESSITATED ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Bone Notching

  MAUDE report 24246031 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT THE FEMORAL JIG LOCKING MECHANISM BROKE. THE EVENT DID NOT HAPPENED DURING A SURGERY AND IT WAS NOTICED WHEN SETTING THE JIG UP FOR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236332 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE ATTUNE DISTAL FEMORAL JIG ARRIVED WITH A BROKEN PIECE.

  Patient problems: Insufficient Information

  MAUDE report 23926739 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  OUTRIGGER SLIDE FROM DISTAL FEMORAL JIG LOST BY FACILITY SPD. 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 PATIENT INVOLVEMENT, 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 23828312 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Illegible Information; Detachment of Device or Device Component; Illegible Information

  IT WAS REPORTED THAT THE DISTAL FEMORAL CUTTING GUIDE HAS A PIECE MISSING. IT WAS FURTHER OBSERVED THAT THE NUMBERS ON THE DEVICE WERE BECOMING HARD TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586784 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE A SMALL METALLIC BULLET FROM THE ATTUNE FEMORAL JIG FELL OFF WHILE THE JIG WAS BEING PINNED. THE PIECE WAS RETRIEVED, THE CASE CONTINUED WITHOUT DELAY, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569283 ↗
• MalfunctionNov 12, 2025Break; Break

  DURING THE PROCEDURE, WHEN OPENING THE INSTRUMENTS AND LOOKING FOR THE NECESSARY PIECES FOR THE SURGERY, IT IS EVIDENT THAT THE FEMORAL CUTTING PIECE IS BROKEN, AS SHOWN IN THE PHOTOGRAPHIC EVIDENCE. HOWEVER, THE SURGERY IS MANAGED TO GO AHEAD WITH THIS PIECE IN THIS CONDITION, COMPLETING THE PROCEDURE SUCCESSFULLY, WITHOUT DISCOMFORT TO THE SURGEON, WITHOUT AFFECTING THE PATIENT, AND WITHOUT ALTERATIONS IN SURGICAL TIMES. UPON COMPLETION, A REPORT IS LEFT IN THE CASE REPORT AND THIS MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533281 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIBIAL JIG WAS DROPPED IN SURGERY SET UP AND EXPLODED ON THE FLOOR. DISTAL CUT BLOCK CLAMP ATTACHMENT. RED TIP BROKE OFF IN SURGERY SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513024 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT THE DISTAL FEMORAL JIG BROKE DURING SURGERY. THIS DID NOT IMPACT THE TIME LENGTH OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487720 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECE WOULD NOT THREAD. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472611 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE GROMMETS FELL OUT OF JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303420 ↗
• MalfunctionSep 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. THE PRODUCT WAS USED ON (B)(6) AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, WHILE SORTING INSTRUMENTS FOR THE NEXT OPERATION, A WIRE-LIKE PART ON THE OUTRIGGER SLIDE WAS FOUND TO BE PROTRUDING OUTWARD, DESPITE ITS INHERENT DESIGN NOT BEING EXPOSED. THIS PROTRUSION IS NOT SEEN ON NORMAL PRODUCTS. THIS PRODUCT WAS NOT USED DURING THE OPERATION ON MONDAY, SEPTEMBER 1ST, AND THE SAME PRODUCT AT ANOTHER FACILITY WAS USED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075298 ↗