ATTUNE 2545-00-546Recalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 10603295132868), received between Jun 21, 2017 and Sep 10, 2026 — classified as 301 malfunctions.

The most frequently reported specific device problem is “Break” (232 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 12, 2015Class IITerminated

   Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

   Z-2139-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 301 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724075 ↗
• MalfunctionAug 11, 2026Break

  It was reported that the attune 5-6 5mm broke into 2 pieces. Both pieces removed from field. Surgery time was not extended.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208709 ↗
• MalfunctionJul 31, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098987 ↗
• MalfunctionApr 20, 2026Crack

  IT WAS REPORTED THAT DURING INSTRUMENT ASSEMBLY AFTER THE CASE IT WAS FOUND THAT TWO PLASTIC INSTRUMENTS WERE CRACKED A FEMORAL IMPACTOR DEVICE AND A TRIAL INSERT EXTRACTOR DEVICE. NO PARTS WERE LEFT BEHIND IN THE PATIENT. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924864 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT THE TIBIAL TRIAL LOCKING FOOT SNAPPED OFF. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896837 ↗
• MalfunctionApr 8, 2026Crack

  IT WAS REPORTED THAT THE DURING INSPECTION IN SPD IT WAS NOTICED THAT INSTRUMENTS WERE CRACKED. THEY DID NOT BREAK IN ANY PIECES JUST CRACKED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821948 ↗
• MalfunctionMar 31, 2026Break

  IT WAS OBSERVED BY CENTRAL SUPPLY THAT THE INSERT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742119 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT BROKEN DURING TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698297 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT TKA FOR KNEE OA. WHEN A FEMORAL COMPONENT WAS IMPACTED DURING THE SURGERY, THE IMPACTOR IN QUESTION BROKE. THE DAMAGED DEVICE WAS REMOVED IMMEDIATELY AND MOVED TO A NON-STERILE AREA. A SPARE IMPACTOR WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557355 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT SPRING MISSING FROM BOTTOM OF TRIAL. IT WAS FOUND AFTER THE CASE WHEN REPROCESSING, THIS SURFACE TRIAL WAS NOT USED DURING THE CASE ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513148 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE SHIM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377681 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT SURGEON BROKE THE ARTICULAR SURFACE WHEN TRYING TO EXTRACT THE TRIALS. IT WAS REPORTED THAT THE ARTICULAR TRIAL WAS SPLIT INTO TWO PIECES AND ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229574 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT THE PS TRIAL LINER HAD A BROKEN PEG ON ITS UNDERSIDE, AND THE LUG DRILL WAS DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167405 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS MISSING A SPRING. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956973 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT ATTUNE SIZE 6 RP ARTIC SURF BROKE INTO TWO PIECES. BOTH PIECES WERE RETRIEVED FROM THE STERILE FIELD. SURGERY TIME WAS NOT EXTENDED. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758116 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE PEGS BROKE OFF TRIALS. SCRUB THREW AWAY BEFORE USER COULD GET THEM TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645397 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE PEGS BROKE OFF TRIALS. SCRUB THREW AWAY BEFORE USER COULD GET THEM TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645381 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435890 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL KNEE. DURING TRAILING, THE LOCKING PEG ON THE TIBIAL INSERT TRIAL SHEERED OFF. ALL PIECES WERE PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423981 ↗
• MalfunctionSep 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTUNE TRIAL INSERT WAS FOUND BROKEN IN THE SET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049607 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22997661 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE PEGS ON THE SIZE 6 RP ARTICULAR SURFACE WERE SHEARED OFF. SURGERY WAS NOT EXTENDED DUE TO THIS EVENT. THERE WAS NO ADVERSE OUTCOME AS A RESULT OF THIS INCIDENT EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677327 ↗
• 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 22326908 ↗
• MalfunctionJun 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON MENTIONED THE ANTERIOR BROACH HANDLES ARE BECOMING LOOSE AND ASKED IF THEY CAN BE REPLACED. NO ADVERSE EVENTS. NO HARM TO PATIENT. NO EXTRA TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320180 ↗
• MalfunctionJun 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON MENTIONED THE ANTERIOR BROACH HANDLES ARE BECOMING LOOSE AND ASKED IF THEY CAN BE REPLACED. NO ADVERSE EVENTS. NO HARM TO PATIENT. NO EXTRA TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319854 ↗