ATTUNE 2545-00-127Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295427551), received between Jul 10, 2019 and Jun 17, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Material Deformation

  IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE DEVICE HAD BECOME MISSHAPEN OVER TIME. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534238 ↗
• MalfunctionMay 11, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WON'T SIT IN TRAY. DAMAGED AT THE BOTTOM. IT WAS BROKEN AT THE BOTTOM BENT AND WON'T SIT IN TRAY. THERE WAS NO TIME ADDED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142613 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT THE ATTUNE SYSTEM IMPACTOR, ATTUNE FB TIBIAL IMPACTOR, ATTUNE FEMORAL IMPACTOR, AND ATTUNE EVAL BLT NO-SPK SZ 1-10 WERE BROKEN INTRAOPERATIVELY. THE EVENT INVOLVED A BROKEN MODULAR FB AND FEMORAL IMPACTOR, A BROKEN TIBIAL EVALUATION BULLET, AND A UNIVERSAL IMPACTOR. THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS, AND NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887740 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302612 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT THE 5 AND 6 RP INSERT TRIALS WERE BROKEN AND EVAL BULLETS WERE CHIPPED.

  Patient problems: Insufficient Information

  MAUDE report 21253176 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT THE 5 AND 6 RP INSERT TRIALS WERE BROKEN AND EVAL BULLETS WERE CHIPPED.

  Patient problems: Insufficient Information

  MAUDE report 21251170 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED THAT THERE WERE 2 BROKEN EVAL BULLETS THAT NEED REPLACED, AND A BROKEN SURFACE PIECE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770620 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED THAT THERE WERE 2 BROKEN EVAL BULLETS THAT NEED REPLACED, AND A BROKEN SURFACE PIECE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770617 ↗
• MalfunctionJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE FEMORAL AND RP IMPACTORS BROKE, ANGLE WING BENT, EVAL BULLET OLD AND WORN, RP TRIAL POST IS CRACKED. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19597461 ↗
• MalfunctionJun 24, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE FEMORAL AND RP IMPACTORS BROKE, ANGLE WING BENT, EVAL BULLET OLD AND WORN, RP TRIAL POST IS CRACKED. UNKNOWN SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19597411 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT THE EVAL BULLET WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810083 ↗
• MalfunctionNov 15, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE EVALUATION BULLET HAD SCORING MARKS ON ITS SURFACE, RESTRICTING THE MOVEMENT OF RP ARTICULATING SURFACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141639 ↗
• MalfunctionNov 15, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE EVALUATION BULLET HAD SCORING MARKS ON ITS SURFACE, RESTRICTING THE MOVEMENT OF RP ARTICULATING SURFACES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141625 ↗
• MalfunctionSep 24, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT UPON INSPECTION OF THE BULLETS, I NOTICED ALL WERE NOT SITTING FLUSH WITHIN THE TIBIAL BASE TRIAL, THEY DO NOT APPEAR TO BE DAMAGED BUT NONE OF THEM SEAT CORRECTLY. I COMPARED THEM TO ANOTHER HOSPITAL AND IT APPEARS THEY ARE SLIGHTLY OUT OF SHAPE CAUSING THIS OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476172 ↗
• MalfunctionAug 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL TRAY TRIAL WOULDN¿T CONNECT TO THE TRAY HANDLE AND THE INSERT WOULDN¿T SIT DOWN INSIDE THE TRAY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308365 ↗
• MalfunctionNov 23, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EVAL BULLET NO LONGER SITS FLUSH IN TIBIA TRAY. NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10888248 ↗
• MalfunctionJul 10, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ONCE THE REVISION SURGERY WAS COMPLETED (IT¿S REPORTED AS (B)(4)). IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO CHECK EXTENSION AND FLEXION OF THE PATIENT'S KNEE JOINT DURING THE REVISION SURGERY ON (B)(6) 2019 BY USING THE TIBIAL INSERT TRIAL (P/N: 251700406) WITH THE INSTRUMENTS WHICH WERE COMBINED WITH THE EVALUATION BULLET NO SPIKE (P/N: 254500127) AND THE KEEL PUNCH (P/N: 254500173), HOWEVER THE SHAPE OF THE TIBIAL INSERT TRIAL DID NOT FIT WITH THE INSTRUMENTS AND DID NOT ENGAGED. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775886 ↗