ATTUNE 2545-00-503Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295132431), received between Sep 8, 2017 and May 27, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE METAL SPRING RING USED TO SECURE THE SHIM BECAME DISLODGED INTRAOPERATIVELY WHEN THE NURSE REMOVED THE SHIM FROM THE DEVICE. LOOSENING OF THE SPRING RING WAS ALSO CONFIRMED IN OTHER TRIAL INSERTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY, AND X-RAY CONFIRMED NO FRAGMENTS OR COMPONENTS REMAINED IN THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE OR INVOLVEMENT. THE COMPLAINT DEVICES WERE AVAILABLE FOR RETURN EXCEPT FOR ONE DEVICE, WHICH WAS RETAINED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299209 ↗
• MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING ON ARTICULATING SURFACE TRIAL POPPED OFF AND INSTRUMENT WAS NEVER USED. THE EVENT DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992649 ↗
• 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 21968482 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRIALS HAD ONE MISSING SPRING. IT WAS POINTED OUT BY THE STERILE PROCESSING DEPARTMENT AFTER THE CASE. IT WAS UNKNOWN IF THEY CAME OFF IN SURGERY OR WHILE BEING WASHED. THESE WERE USED MULTIPLE TIMES THROUGHOUT THE WEEK BUT IT WAS JUST NOTICED THAT THESE WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383723 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RETENTION SPRING WAS DISLODGED FROM BACK OF TRAIL. SPRING COLLECTED FROM SITE AND OP SITE WAS IRRIGATED AND X-RAYS TAKEN TO CONFIRM NO REMAINING PIECES. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19370864 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: IT WAS NOTICED AT THE START OF SURGERY THAT THE SPRING WAS MISSING SO IT WAS NOT USED FOR THE PROCEDURE AND AN ALTERNATIVE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711841 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT ATTUNE FB PS ARTIC SURF SZ3 WAS DAMAGED DURING PROCEDURE, ALL PARTS REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996401 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT THE SPRING BROKE OFF AND THE SHIMS CANNOT ATTACH. NO PATIENT INVOLVEMENT. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930395 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT THE SPRING BROKE OFF AND THE SHIMS CANNOT ATTACH. NO PATIENT INVOLVEMENT. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930365 ↗
• MalfunctionJul 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COUPLING SPRINGS OF THE HEIGHTS TRIAL FOR THE INSERT WERE IN POOR CONDITION. IT WAS DIFFICULT TO ATTACH THE HEIGHTS TO TRIAL INSERTS, AND OBTAIN THE FINAL INSERT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 17387960 ↗
• MalfunctionJul 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE COUPLING SPRINGS OF THE HEIGHTS TRIAL FOR THE INSERT WERE IN POOR CONDITION. IT WAS DIFFICULT TO ATTACH THE HEIGHTS TO TRIAL INSERTS, AND OBTAIN THE FINAL INSERT NUMBER.

  Patient problems: Insufficient Information

  MAUDE report 17387950 ↗
• MalfunctionOct 16, 2022Break; Break

  INSTRUMENT BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613022 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE IN HALF, ALL PARTS WERE RECOVERED AND THE SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549876 ↗
• MalfunctionOct 6, 2022Break; Break

  IT WAS REPORTED THAT THE SHIM BROKE IN HALF, ALL PARTS WERE RECOVERED AND THE SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549870 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT THE INSERT BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151746 ↗
• MalfunctionOct 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NURSE REPORTED AN ATTUNE SPACER BLOCK MISSING A SPRING, REQUIRES REPLACEMENT. ALSO AN ATTUNE SIZE 3 TRIAL IS MISSING A SPRING AND REQUIRES REPLACEMENT. FINALLY A 40MM TRIAL LINER BROKE AND REQUIRES REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708803 ↗
• MalfunctionSep 29, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE PROCESSING AND PUTTING TRAYS BACK TOGETHER, IT WAS NOTICED SOME BROKEN ARTICULAR TRIALS AND SOME WITH MISSING SPRINGS. THESE TRIALS WERE REMOVED FROM THE SETS AND ARE NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548178 ↗
• MalfunctionJun 18, 2021Use of Device Problem; Use of Device Problem

  DURING THE SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE INSTRUMENT PIECE WAS WITHOUT ONE OF THE SPRINGS. ONCE THE PROCEDURE WAS FINISHED, IT WAS MARKED WITH RED TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026046 ↗
• MalfunctionNov 2, 2020Component Missing; Component Missing

  TRIAL ATTUNE LINERS LOST THEIR BALLSEALS DURING THE STERILIZATION PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771715 ↗
• MalfunctionAug 4, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE ATTUNE SIZE 4 FB ARTIC SURF WAS DISCOVERED TO BE MISSING A SPRING ON THE UNDER SURFACE. THIS EVENT OCCURRED IN THE CENTRAL STERILE PROCESSING AND NO PATIENT WAS INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364285 ↗
• MalfunctionJul 22, 2020Break; Component Missing; Material Twisted/Bent; Naturally Worn; Break; Component Missing; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THEY HAVE SEVERAL ITEMS THAT THE CENTRAL STERILE DEPARTMENT WANTS REPLACED, DUE TO BROKEN PIECES. I HAVE 2 ARTIC SURF PIECES MISSING SPRINGS. I HAVE 1 ARTIC SURF MISSING AN ENTIRE PRONG, THEY DO NOT HAVE MISSING PRONG, THERE WAS JUST A HOLE WHERE IT USED TO BE. THEY HAVE IMPACTION HANDLE THAT THE RED TRIGGERS AS BROKEN OFF, THEY HAVE ALL 3 PIECES, HANDPIECE, TRIGGER, AND SPRING. NONE OF THESE ITEMS WERE BROKEN IN SURGERY, NONE OF THESE ITEMS DELAYED A SURGERY, NO ONE WAS INJURED BY THESE ITEMS. THEY ARE BROKEN, MISSING PIECES FROM NORMAL WEAR AND TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10309767 ↗
• MalfunctionMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884328 ↗
• MalfunctionNov 27, 2019Entrapment of Device; Material Fragmentation; Entrapment of Device; Material Fragmentation

  IT WAS REPORTED THAT THE TKA SURGERY WAS PERFORMED ON (B)(6) 2019 BY USING THE TIBIAL INSERT TRIAL (P/N: 254500973). THE SURGERY WAS COMPLETED SMOOTHLY. SINCE THE TIBIAL INSERT TRIAL DID NOT COME OUT FROM THE KNEE JOINT SEPARATELY, IT WAS NOT CHECKED THE RING PART OF THE TIBIAL INSERT TRIAL. THE SALES REP OBTAINED THE INFORMATION FROM THE DOCTOR ON NOV 1ST, 2019 THAT THERE WAS SOMETHING LIKE A SPRING ON X-RAY. THE SALES REP CONFIRMED THE X-RAY THAT THERE WAS A HIGH POSSIBILITY OF SPRING OF THE INSERT TRIAL CAME OFF AND HAD BEEN REMAINING IN THE PATIENT'S THE LATERAL TIBIAL POSTERIOR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384184 ↗
• MalfunctionOct 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  SPRINGS DAMAGED THROUGH NORMAL USE. COME OFF DURING SURGERY. ONE HAS ALREADY BEEN LOST DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251897 ↗
• MalfunctionOct 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  SPRINGS DAMAGED THROUGH NORMAL USE. COME OFF DURING SURGERY. ONE HAS ALREADY BEEN LOST DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251895 ↗