ATTUNE 2545-00-046Recalls & reported problems

Summary

The FDA's MAUDE database contains 396 adverse event reports that list this exact device (DI 10603295130536), received between Jun 28, 2017 and Sep 14, 2026 — classified as 1 injury, 395 malfunctions.

The most frequently reported specific device problem is “Break” (338 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 396 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756972 ↗
• MalfunctionJul 6, 2026Break

  IT WAS REPORTED THAT POSTERIOR CAPTURE SPRING IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717559 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT THE SIZE 6-8 RED CAPTURE PIECE THAT GOES INTO THE FEMORAL CUTTING BLOCK BROKE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486633 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, WHEN MAKING CUTS WITH FOUR IN ON CUT BLOCK, THERE WAS A POP. A COUPLE MINUTES LATER ONE OF THE SILVER NUMBS WAS BROKEN OFF FROM CAPTURE GUIDE AND FOUND. ALL PIECES HAVE BEEN ACCOUNTED FOR. NO COMPLICATIONS OR DELAYS OCCURRED BECAUSE OF THE BROKEN CAPTURE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336098 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT THE ATTUNE FEMORAL IMPACTOR BROKE INTO PIECES WHEN USING TO IMPACT THE DEFINITIVE ATTUNE CEMENTLESS FEMUR IMPLANT USED IN THE CASE. THE POSTERIOR SAW CAPTURE WAS BROKEN WHEN HANDED TO THE SURGEON. THE PLASTIC HOOK THAT SECURES THE CAPTURE TO THE BLOCK FOR USE HAD LOST ITS HOOK PART ON THE TAB THAT HOLDS IT IN A LOCKED POSITION SUCH THAT THE CAPTURE GOOD PULL OR BE SHAKEN OFF THE BLOCK WITHOUT IT HOLDING AS IT SHOULD. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285374 ↗
• MalfunctionMay 14, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, THE SAW CAPTURE ATTACHMENT PIECE BROKE OFF AND IT WILL NOT ATTACH TO THE CUTTING BLOCK. THERE WAS NOTHING LEFT IN PATIENT. THERE WAS NO DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175846 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE RED TAB ON SAW CAPTURE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163774 ↗
• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT RED TAB NO LONGER CAPTURES 4 IN 1 BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149223 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTUNE CUTTING GUIDE POSTERIOR WAS BROKEN. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034177 ↗
• MalfunctionApr 20, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), THE PLASTIC RED PIECE WAS BROKEN ON 6-8 CAPTURE, NOT ALLOWING IT TO LOCK ONTO FEMORAL CUTTING BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925169 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE SIZE 6 FOUR IN ONE CUT BLOCK HAD A METAL BURR IN THE CUT SLOT CAUSING IT TO BIND ON THE SAW BLADE. AND THE 6-8 POSTERIOR CAPTURE RED BUTTON BROKE OFF. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925113 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THE SCRUB TEAM NOTED THAT THE DEVICES ARE BENT. NO ISSUES CAUSED TO THE PROCEDURE OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769298 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT RED LATCH WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 24755086 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT THE RED SAW CAPTURE TAB WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24668392 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT THE ATTACHMENT TAB BROKE OFF DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661780 ↗
• MalfunctionMar 4, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 6-8 POST CAPTURE RED PIECE BROKE AND WOULD NOT STAY ON CUTTING BLOCK, ALSO NEEDED A NEW FEM SIZER, ALL WHITE PAINT MISSING CANNOT READ THE SIZES OR ROTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507925 ↗
• MalfunctionMar 4, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ATTUNE MOD POST SAW CAP SZ 6-8 AND ATTUNE MES SIZING/ROT GDE EXPERIENCED ISSUES DURING USE. THE EVENT INVOLVED THE RED PIECE OF THE POST CAPTURE BREAKING AND FAILING TO STAY ON THE CUTTING BLOCK, AS WELL AS THE FEMORAL SIZER LOSING ALL WHITE PAINT, MAKING IT IMPOSSIBLE TO READ SIZES OR ROTATION. BOTH DEVICES BROKE INTRAOPERATIVELY, SEPARATING INTO TWO OR MORE PIECES, AND COULD NOT RETAIN THEIR INTENDED FUNCTION. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE, AND NO OBSERVABLE CLINICAL SYMPTOMS OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507868 ↗
• MalfunctionFeb 18, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RED TAB ON THE SAW CAPTURE WAS BROKEN, PREVENTING THE DEVICE FROM LOCKING INTO THE BLOCK. THE EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377530 ↗
• MalfunctionFeb 17, 2026Break

  BROKEN KNEE INSTRUMENTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367197 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT RED CHIP BROKE ON CAPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220993 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT THE SAW CAPTURE RED TAB BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092368 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE RED KNOB ON THE SAW CAPTURE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053768 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT THE RED LOCKING TAB ON 6-8 SAW CAPTURE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022061 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION OF SOME ATTUNE INSTRUMENTS BEING SET UP FOR A TOTAL KNEE ARTHROPLASTY CASE, THE SCRUB TECH NOTICED THAT THE RED PLASTIC LOCKING MECHANISM ON THE SIZE 6-8 POSTERIOR SAW CAPTURE WAS BROKEN. A SECOND TRAY, CONTAINING THE SAME INSTRUMENT, WAS OPEN AND UTILIZED IN THE CASE. THE SECOND TRAY WAS OPENED BEFORE THE PATIENT ENTERED THE OPERATING ROOM, SO THE START OF THE CASE WAS NOT DELAYED DUE TO THE BROKEN INSTRUMENT. IT IS UNKNOW WHEN, WHERE, OR HOW THE LATCH PORTION ON THE UNDERSIDE OF THE PLASTIC LOCKING MECHANISM BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981146 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE 6-8 CAPTURE WAS FOUND BY CENTRAL STERILE WITH A BROKEN CLIP. THE ATTUNE REV LONG BROACH BOLT WAS FOUND BY CENTRAL STERILE WITH CROSSED THREADS. THE RED CLIP IS BROKEN THAT LOCKS THE CAPTURE ONTO THE BLOCK. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957142 ↗