ATTUNE 2545-11-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10603295499213), received between Jul 10, 2024 and Sep 22, 2026 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Break” (66 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that during an unspecified surgical procedure it was observed that the cementless patella clamp was broken. It was reported that the winding piece snapped off while implanting. It was reported that there was no delay in the procedure due to the event. It was reported that there was injury to the patient or user. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852778 ↗
• MalfunctionSep 16, 2026Break

  It was reported that during implantation of the affixium patella, the patella handle broke off the end of the clamp. No additional information given.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794318 ↗
• MalfunctionSep 16, 2026Break

  It was reported that during impaction of the femoral implant, the femoral impactor was broke. During implantation of the patella implant, the patella clamp was broke. These did not impact the length of the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785807 ↗
• MalfunctionSep 11, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739959 ↗
• MalfunctionAug 28, 2026Break

  It was reported that the handle was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498460 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147475 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE HANDLE ON THE CLAMP WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486794 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT THE PF PATELLA CLAMP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355302 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT WHILE TIGHTENING THE HANDLE, IT SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163700 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT THE HANDLE SNAPPED WHILE TIGHTENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942355 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT THE PRESSFIT PATELLA CLAMP BROKE. ALL PIECES WERE RETRIEVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886628 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT THE PATELLA CLAMP HANDLE BROKE WHILE COMPRESSING THE PATELLAR IMPLANT INTO THE BONE. THERE WAS A SHORT DELAY WHILE OBTAINING SOME VISE GRIPS TO BE ABLE TO REMOVE THE CLAMP, AS IT WAS STILL TIGHT AGAINST THE IMPLANT. NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846343 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT ATTUNE CEMENTLESS PATELLA CLAMP HANDLE SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821585 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT AS THE DOCTOR WAS IMPLANTING THE PATELLA, THE CEMENTLESS PATELLA CLAMP BROKE AT THE T- HANDLE PART. ALL BROKEN PIECES WERE RETRIEVED. THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820897 ↗
• MalfunctionApr 3, 2026Mechanical Jam

  IT WAS REPORTED THAT THE PATELLA CLAMP IS HARD TO TWIST AND CLAMP DOWN. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775653 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT THE HAND CRANK ON THE AFFIXIUM PATELLA CLAMP HAD BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755605 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT PRESSFIT PATELLA CLAMP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744879 ↗
• MalfunctionMar 26, 2026No Apparent Adverse Event

  TOTAL KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701723 ↗
• MalfunctionMar 20, 2026Break; Unintended Movement

  IT WAS REPORTED THAT HANDLE OF CEMENTLESS PATELLA CLAMP CAME OFF DURING COMPRESSION OF PATELLAR IMPLANT TO PATELLA. NO ADDITIONAL INFORMATION AVAILABLE REGARDING PATIENT OR EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647795 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT THE PRESSFIT PATELLA CLAMP WAS BROKEN WHEN THE SURGEON TIGHTENED DOWN THE CLAMP TO PRESS THE PRESSFIT PATELLA DOWN. PATELLA WAS DOWN AND NO TIME WAS ADDED TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593951 ↗
• MalfunctionMar 11, 2026No Apparent Adverse Event

  THE DEVICE WAS REPORTED FOR UNKNOWN REASON. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ATT PATELLA CLAMP POR HAD THE T-HANDLE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574836 ↗
• MalfunctionMar 10, 2026Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT DURING OPERATION OF THE NON-CEMENT EVAL BULLET AND TIBIAL PEG RELIEF DRILL WOULD NOT SEAT PROPERLY, NO PIECES BROKE OFF, NO HARM TO THE PATIENT, NO DELAY IN SURGICAL CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557201 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT SURGEON WAS PRESSING THE PATELLA ON AND SURGEON BROKE THE HANDLE OFF OF THE CLAMP ITSELF. PATELLA WAS FULLY SEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24522239 ↗
• MalfunctionMar 5, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED, PROVIDING ANSWERS FROM THE FOLLOWING QUESTIONS: 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE REPORTED DEVICE? DON'T KNOW THE LOT# 2. DID IT BROKE INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, WORN OR CROSS THREADED? BROKE INTO 2 PIECES. WHERE THE T-HANDLE CONNECTS IT BROKE OFF. I'VE ATTACHED A PICTURE OF WHERE IT BROKE. 3. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? SEARCHED FOR POSSIBLE TINY FRAGMENTS BUT NONE WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518678 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT THE PRODUCTS BROKE DURING NORMAL USE. THE LOCKING MECHANISM WAS FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433320 ↗