ATTUNE 2545-00-504Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10603295132448), received between Aug 9, 2017 and Jun 18, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Break” (52 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 12, 2015Class IITerminated

   Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

   Z-2137-2015 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AT THE TIME OF USING THE ATTUNE FB PS ARTIC SURF SZ4 TEST, IT BROKE INTO ONE OF ITS ATTACHMENTS, WHERE THE INSERT HEIGHTS ARE MOUNTED; HOWEVER, THE OTHER TEST THEY SENT WAS USED AND EVERYTHING WAS DONE SUCCESSFULLY. THERE WAS NO DISCOMFORT ON THE PART OF THE SPECIALIST NOR WERE THERE ANY DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553211 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT SURGERY FOR OA ON LEFT KNEE WITH THE PRODUCT IN QUESTION. IN THE SURGERY, THE SURGEON ATTEMPTED TO REMOVE THE INSERT TRIAL, BUT IT WAS DIFFICULT TO REMOVE. WHEN HE TRIED TO LIFT IT UP WITH AN ELEVATORIUM, THE TRIAL BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596867 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT THE SPRINGS ON THE INSERT TRIAL ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336805 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT THE SPRINGS ON THE INSERT TRIAL ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336792 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT THE TIBIA TEST WAS BROKEN WHILE REMOVING THE IMPLANT. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010293 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN INSERTING THE TRIAL INSERT AND LEVERING IT OUT TO INSERT A LARGER AUGMENTATION, THE INSERT FRACTURED. BOTH PIECES ARE REMOVED WITHOUT ANY HARM AND ANOTHER INSERT WAS USED TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063094 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE WHEN THE SPECIALIST WAS GOING TO IMPACT WITH THE FEMORAL IMPACTOR, THE BLOW HE GAVE WITH THE HAMMER, THE DEVICE BROKE. IMMEDIATE SOLUTION WAS TO GIVE THE SPECIALIST ANOTHER IMPACTOR OF THE SAME CHARACTERISTICS. IN ADDITION TO THIS DURING THE PROCEDURE IT IS EVIDENT THAT THE TEST INSERTS OF 3 AND 4 REF * AND REF * DO NOT HAVE THE SPRINGS BUT OF THESE IT WAS NOT NECESSARY TO USE DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968545 ↗
• MalfunctionMar 27, 2025Break; Break

  IT WAS REPORTED THAT THE SPRING HAVE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 21709491 ↗
• MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING WAS MISSING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445235 ↗
• MalfunctionAug 8, 2024Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TRIAL IS DAMAGED CLOSE TO THE STAB. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19937555 ↗
• MalfunctionAug 5, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGEONS CURRENT PLAN IS TO MONITOR THE PATIENT CLOSELY AND THEN MAKE A DECISION ON WHETHER TO REMOVE THE BALSEAL SPRING OR LEAVE IT LONG TERM.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19905057 ↗
• MalfunctionJul 1, 2024Break; Break

  THE SPRING ON THE END OF THE ARTICULATING SURFACE CAME OFF OF THE BOTTOM OF THE INSTRUMENT, NOTHING WAS LEFT IN THE PATIENT, IT DID NOT CAUSE ANY DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19648081 ↗
• MalfunctionMay 31, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  SPRING RING DETACHED FROM TRIAL INTRO-OP. IT WAS REPORTED THAT THE PATIENT HAD A KNEE SURGERY ON (B)(6) 2024. TODAY, THE PATIENT HAD A POST-OPERATIVE FILM, AND WAS FOUND A FOREIGN MATTER IN THE KNEE JOINT. AFTER CHECKED, THE FOREIGN MATTER IS THE SPRING RING OF THE TRIAL. THE PATIENT RECOVERED WELL CURRENTLY, NO PLAN TO REMOVE THE SPRING RING SO FAR.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436178 ↗
• MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: A. IS THERE ANY SURGICAL DELAY? IF YES, PLEASE MENTION DURATION OF THE DELAY. NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. C. WAS THERE ANY ALLEGED DEFICIENCY TO THE REPORTED DEVICES? IF YES, PLEASE PROVIDE DETAILS. IS IT BREAK, BENT, CRACKED, STRIPPED, WORN OR CROSS THREADED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791741 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED THAT WHEN REMOVING ARTIC SURF WITH A TIBIAL TRIAL EXTRACTOR, THE SHIM CAME OFF AND THE SPRING CAME OFF AND RETRIEVED FROM BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562705 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  WHEN REMOVING THE SIZE 4 TIBIA TEST INSERT, IT IS EVIDENT THAT THE THREADED WIRE IN ONE OF ITS COMPARTMENTS WHERE THE HEIGHT OF THE INSERT IS INSERTED IS LOOSE. THERE WERE NO INCONVENIENCES ON THE PART OF THE SPECIALIST AND IT WAS ACHIEVED SUCCESSFULLY. THIS THREADED WIRE HELPS TO MAINTAIN THE TEST HEIGHT OF THE INSERT MORE FIRMLY WHEN SETTING THE TEST HEIGHT OF THE INSERT. IT WAS STILL USED TAKING CARE NOT TO LET THE TEST HEIGHT OF THE INSERT GO OUT. INSERT. THE WIRE THAT COMES WITH THE TIBIA TEST INSERT WAS LOOSE, THE WIRE LOST ITS THREADED SHAPE AND CAME OUT OF WHERE IT SHOULD BE, THIS WIRE HELPS TO MAKE IT FIRMER WHEN PLACING THE TEST HEIGHT OF THE INSERT, DESPITE THAT THERE WAS NO ADDITIONAL TIME IN THE SURGERY AND THE PATIENT DID NOT SUFFER ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18494305 ↗
• MalfunctionJan 3, 2024Break; Break

  ATTUNE INSERT TRAY GASKET GETS STUCK AND BREAKS DURING USE IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information

  MAUDE report 18440707 ↗
• MalfunctionNov 17, 2023Crack; Crack

  IT WAS REPORTED THAT IT WAS FOUND THAT THE POLY TRIAL WAS CRACKED AFTER TRIALING. VISUAL EXAMINATION OF THE RETURNED TRIAL ALSO FOUND THAT ONE OF THE POSTS HAS BEEN CHIPPED. NO ADVERSE EFFECTS. NO TIME ADDED TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159060 ↗
• MalfunctionJul 14, 2023Break; Break

  IT WAS REPORTED THAT THE INSERT BEARING WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325787 ↗
• MalfunctionMay 31, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PART THAT BROKE OFF THE INSTRUMENT WAS THE PEG ON THE BACK. NO DELAYS IN THE PROCEDURE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032787 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE SPRING IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010643 ↗
• MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SPRING IS MISSING FROM BACK OF ARTICULATING SURFACE TRIAL. DISCOVERY WAS MADE IN PRE-OP. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773805 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT BEARING BROKE ON INSERT TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567528 ↗
• MalfunctionMar 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SIZE 4 FB TIBIAL ARTICULATION BASE SPRING WAS FELL OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461819 ↗
• MalfunctionDec 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN INSPECTION OF THE INSTRUMENTS IT WAS FOUND THAT ONE OF THE BALSEALS IS MISSING FROM EACH SURFACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932610 ↗