ATTUNE 2545-01-055Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10603295442929), received between Dec 20, 2017 and May 29, 2026 — classified as 128 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (63 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Contamination /Decontamination Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY SURGERY, SOMETHING LODGED IN THE CLAMP SPRING PREVENTED THE CLAMP FROM CLOSING FULLY. NOTHING WAS LEFT IN THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334067 ↗
• MalfunctionMay 19, 2026Structural Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SWIVEL BOW ROLLER HAD AN ISSUE WITH THE RED LATCH. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO UNLOCK FROM THE OPEN POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222830 ↗
• MalfunctionMay 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA SQUEEZER HANDLE WON'T LOCK/UNLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149461 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE WAS WORN OUT NOT HOLDING THE PATELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116054 ↗
• MalfunctionMar 4, 2026Mechanical Jam

  IT WAS REPORTED THAT THE PATELLAR CLAMP FOR FINAL IMPLANT WOULD NOT RELEASE ONCE IMPLANT CEMENT WAS FINALIZED. REQUIRED ADDITIONAL TOOLS (COB) TO RELEASE THE RATCHETING LATCH WHICH HOLDS THE CLAMP IN PLACE. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511931 ↗
• MalfunctionFeb 2, 2026Structural Problem

  IT WAS REPORTED THAT THE PATELLA CLAMPS WOULDN¿T LOCK, THE ATTUNE IMPACTION HANDLES BROKE, AND THE IMPACTORS HAD CRACKS IN THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235818 ↗
• MalfunctionFeb 2, 2026Structural Problem

  IT WAS REPORTED THAT THE PATELLA CLAMPS WOULDN¿T LOCK, THE ATTUNE IMPACTION HANDLES BROKE, AND THE IMPACTORS HAD CRACKS IN THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235702 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT (2) BROKEN PATELLA IN 2 SEPARATE TRAYS WERE FOUND (1) CR EXTENSION/PS FLEXION/EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189525 ↗
• MalfunctionJan 22, 2026Mechanical Jam

  TKA: ATTUNE PATELLA CLAMP STAY BLOCKED AFTER CEMENTING OF THE PATELLA. IMPOSSIBLE OPEN THE CLAMP. INSTRUMENT NEEDED TO BE DIASSAMBLED TO BE OPEN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146015 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555653 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555636 ↗
• MalfunctionNov 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA CLAMP WOULD NOT HOLD ATTACHMENTS SECURELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523190 ↗
• MalfunctionNov 6, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE CLAMP LOCK WOULD NOT LOCK. THE SURGEON HAD TO TAKE EXTRA TIME TO RELEASE THE CLAMP.

  Patient problems: Insufficient Information

  MAUDE report 23486831 ↗
• MalfunctionNov 4, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT PATELLA CLAMP WILL NO LONGER LOCK IN TO CLAMP DOWN THE PATELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469526 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING TRIALING OF THE STD SMALL STEM TRIAL, THE TRAIL WOULD NOT ENGAGE THE INSERTION HANDLE. THE SHELL WAS ALSO HARD TO TREAD INTO THE TRIAL. THE THREADS ON THE TRIAL STEM WERE CROSS TREADED AND VISIBLY DAMAGED. THE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397322 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE ATTUNE PATELLA DRILL CLAMP LOCKING MECHANISM WAS BROKEN. THERE WERE NO DELAYS, NO COMPLICATIONS AND ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393637 ↗
• MalfunctionOct 23, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PATELLA SQUEEZER NOT RELEASING PROPERLY. THE CLAMP WAS GETTING STUCK IN THE LOCK POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373746 ↗
• MalfunctionSep 11, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE BALL BEARING WAS LOOSE AND WON'T ALLOW THE TRIALS OF CLAMP TO HOLD TIGHT. IT KEEPS SLIPPING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026790 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018658 ↗
• MalfunctionSep 8, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THE LOCKING MECHANISM IS BROKEN AND WON'T LOCK ANYMORE. 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 22995030 ↗
• MalfunctionAug 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA CLAMP DIDN'T SECURELY HOLD ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879637 ↗
• MalfunctionAug 19, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A BROKEN PATELLA CLAMP. A REPLACEMENT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841601 ↗
• MalfunctionAug 6, 2025Structural Problem; Mechanical Jam; Structural Problem; Mechanical Jam

  IT WAS REPORTED THAT AFTER CEMENTING THE PATELLA, THE DOCTOR COULDN'T UNLOCK THE CLAMP. IT WANTED TO STAY LOCKED. IT IS VERY DIFFICULT TO UNLOCK IT ONCE IT'S COMPRESSED AND LOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731171 ↗
• MalfunctionJul 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON TRIED TO PUT PATELLA SIZER TRIAL ON CLAMP AND SIZER WOULD NOT SNAP ON. ANOTHER PATELLA SIZER TRIAL WAS USED TO DETERMINE WHICH INSTRUMENT WAS FAULTY. SURGEON CONCLUDED THE ISSUE WAS THE CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664394 ↗
• MalfunctionJul 9, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT ATTUNE PATELLA CLAMP HAD WORN DOWN AND THE CEMENTING BUTTON/DRILL GUIDE NO LONGER STAYS LOCKED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22463971 ↗