ATTUNE 2545-01-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295442943), received between Feb 21, 2019 and Nov 17, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569801 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569790 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569503 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555644 ↗
• MalfunctionDec 14, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT PATELLA CLAMP IS WON¿T FULLY LOCK DOWN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983817 ↗
• MalfunctionAug 23, 2022Structural Problem; Device-Device Incompatibility; Structural Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA TRIAL WAS UNABLE TO CLIP INTO INTO PATELLA DRILL HANDLE. CONTINUOUSLY GOT STUCK AND LOCKING MECHANISM DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278086 ↗
• MalfunctionApr 18, 2022Structural Problem; Structural Problem

  THE ATTUNE PATELLA CLAMP FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135297 ↗
• MalfunctionSep 24, 2021Naturally Worn; Naturally Worn

  WE NOTICED DURING THE CASE THAT THE BUTTON THAT HOLDS THE TRIALS/CLAMP RINGS DOWN ON THE PATELLA CLAMP WAS WORN DOWN AND WOULDN'T HOLD THEM WELL. THIS DID NOT EFFECT THE TIMING/OUTCOME OF THE CASE AT ALL BECAUSE WE HAD A BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528399 ↗
• MalfunctionAug 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA TRIAL HANDLE WOULD NOT HOLD THE METAL PATELLA DRILL TRIAL. IT WAS ALSO REPORTED THAT THE ORANGE RING THAT ATTACHES TO THE PATELLA SQUEEZER FOR CEMENTING THE PATELLA HAS A PIECE OF RUBBER MISSING FROM THE O-RING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259445 ↗
• MalfunctionJan 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA HOLDER DOES NOT ATTACH TO THE PATELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11174196 ↗
• MalfunctionFeb 21, 2019Break; Break

  BROKEN INSTRUMENTS IN CONSIGNMENT TRAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357389 ↗