ATTUNE 2544-01-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295395393), received between Jan 2, 2019 and May 14, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT ATTUNE SPACER BLOCK IS BROKEN. ALL PIECES RETRIEVED. THERE WAS NO DELAY. NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172943 ↗
• MalfunctionNov 10, 2025Break; Break

  THIS IS REPORT 3 OF 3 OF (B)(4). IT WAS REPORTED THAT THAT ISSUES WERE NOTICED WITH SEVERAL DEVICES, AS FOLLOWS: EMPHASYS IMPACTOR: NORMAL WEAR AND TEAR. THE BIPOLAR HEAD TRIAL: NORMAL WEAR AND TEAR. THE SPACERBLOCK: BROKEN AND WAS MISSING A SPRING. THE LINER TRIAL: HAD A BROKEN TIP. CR FLEXION BASE: BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513240 ↗
• MalfunctionOct 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BEFORE A CASE, THE SCRUB TECH WAS ATTEMPTING TO PUT DOG BONE TOGETHER AND WAS UNABLE TO GET IT TO PROPERLY BE PUT TOGETHER. WAS REMOVED FROM FIELD BEFORE PATIENT WAS IN ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439284 ↗
• MalfunctionOct 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPACER ADAPTOR OFF THE ATTUNE SPACING TRAY HAD A LOOSE ORING AND COULDN¿T BE ATTACHED TO THE SPACER BLOCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324777 ↗
• MalfunctionApr 22, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PRIMARY TOTAL KNEE ARTHROPLASTY, THE CR FLEXION BASE SPACER BLOCK ATTACHMENT WOULD NOT CONNECT PROPERLY TO THE SPACER BLOCK. THE METAL RING ON THE CR FLEXION BASE WAS WARPED SUCH THAT IT WOULDN'T FIT INTO THE SPACER BLOCK. THERE WERE NO BROKEN OFF PIECES. THERE WERE NO COMPLICATIONS OR DELAYS TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159823 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT TRIAL IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465264 ↗
• MalfunctionJul 31, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CR FLEXION ATTACHMENT POINT IS BROKEN OFF AND WOULD NOT CONNECT TO THE DOG BONE DEVICE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424357 ↗
• MalfunctionJul 18, 2023Break; Break

  IT WAS REPORTED THAT INSTRUMENT BROKE WHEN SCRUB TECH TOOK A MALLET TO IT TO TRY AND SNAP IT INTO DOG BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341559 ↗
• MalfunctionMar 15, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT CALCAR PLANERS ARE DULL BOTH ATTUNE SPACER BLOCK SHINS ARE BENT & DO NOT FIT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770493 ↗
• MalfunctionOct 15, 2021Break; Break

  IT WAS REPORTED THAT THE PIECE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638341 ↗
• MalfunctionAug 2, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE RING ON THE FLEXION SPACER BLOCK IS SLIGHTLY WARPED AND IT IS DIFFICULT TO ATTACH TO THE SPACER BLOCK HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259061 ↗
• MalfunctionJun 7, 2021Break; Use of Device Problem; Detachment of Device or Device Component; Break; Use of Device Problem; Detachment of Device or Device Component

  BALLSEAL ON 254401016 HAS FALLEN OUT DURING CLEANING PROCESS. KNOB CONTING THE BALLSEAL HAS BROKEN OFF ON ONE SIDE OF THE 254500524 AFTER CLEANING PROCESS. PLASTIC PART HAS FALLEN OFF ON THE 254500138 AFTER CLEANING PROCESS. NO LOOSE PARTS ARE ATTACHED AND NOTHING AFFLICTED A PATIENT-SITUATION. EVENT OCCURRED POST - OP NO PATIENT INVOLVEMENT.: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953300 ↗
• MalfunctionMar 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SPACER BASE PIECES ARE VERY DIFFICULT TO SNAP INTO PLACE. INSTRUMENTS WERE NOT USED ON A PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11437020 ↗
• MalfunctionAug 25, 2020Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE METAL RING THAT HELPS SNAP ONTO SPACER BLOCK WAS STRETCHED. IT WON'T ATTACH. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10451309 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT THE CR FLEXION SPACER BROKE INTO TWO PIECES DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208816 ↗