ATTUNE 1523-05-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295057598), received between Apr 30, 2021 and Apr 16, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WITH AUGMENTS, POLY AND FEMUR WERE ALL REMOVED DUE TO INSTABILITY. ALL PIECES WERE REMOVED FROM THE PT. AND THE FIELD IMMEDIATELY IN THEIR ENTIRETY AND THERE WAS NO HARM DONE TO THE PATIENT. I HAVE NO FURTHER INFORMATION. AFFECTED SIDE- RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 24903794 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WITH AUGMENTS, POLY AND FEMUR WERE ALL REMOVED DUE TO INSTABILITY. ALL PIECES WERE REMOVED FROM THE PT. AND THE FIELD IMMEDIATELY IN THEIR ENTIRETY AND THERE WAS NO HARM DONE TO THE PATIENT. I HAVE NO FURTHER INFORMATION. AFFECTED SIDE- RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 24896593 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24530564 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968763 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR FOLLOWING A PERIOD OF EXTENDED CROUCHING, HAS EXPERIENCED A TENDER POINT MID RIGHT SHIN AND A PAINFUL RIGHT KNEE DEVICE AND PROCEDURE (RELATEDNESS). RELATEDNESS TO DEVICE: POSSIBLY, RELATEDNESS TO PROCEDURE: POSSIBLY, DATE OF EVENT: UN OCT 2023, DATE OF IMPLANT: ON (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21295914 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR FOLLOWING A PERIOD OF EXTENDED CROUCHING, HAS EXPERIENCED A TENDER POINT MID RIGHT SHIN AND A PAINFUL RIGHT KNEE. DEVICE AND PROCEDURE(RELATEDNESS), RELATEDNESS TO DEVICE: POSSIBLY, RELATEDNESS TO PROCEDURE: POSSIBLY, DATE OF EVENT: UN OCT 2023, DATE OF IMPLANT: (B)(6)2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21295782 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21266733 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOWER RESPIRATORY TRACT INFECTION DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 15-JAN-2022. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION/INJECTED MEDICATION/ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 21264469 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID- (B)(6) STUDY NO-(B)(6) IT WAS REPORTED THAT, CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE POST OPERATIVE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: UNKNOWN DATE OF EVENT (ONSET): 1/13/2022 (UNKNOWN KNEE) TREATMENT: UNSPECIFIED INJECTED MEDICATION, UNSPECIFIED ORAL MEDICATION, AND FEMORAL NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 20544951 ↗
• InjuryMay 20, 2024Migration; Migration

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO SUBSIDENCE OF HER ATTUNE REVISION TIBIAL BASE COMPONENTS. DURING THIS PROCEDURE, TIBIAL INSERT AND TIBIAL BASE COMPONENTS WERE REMOVED. THEY WERE THEN REPLACED BY NEW ATTUNE REVISION COMPONENTS, TO INCLUDE AN ATTUNE REVISION CONE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19350496 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR TENDER POINT MID RIGHT SHIN AND PAINFUL RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: UNK OCT 2023 (RIGHT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 18825525 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR TENDER POINT MID RIGHT SHIN AND PAINFUL RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: UNK OCT 2023. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 18825510 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR OA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023, THE PATIENT WAS RUSHED TO THE HOSPITAL IN THE MORNING DUE TO DIZZINESS, SPEECH DISTURBANCE, AND DECREASED LEVEL OF CONSCIOUSNESS BECAUSE OF SUSPECTED SEPSIS DUE TO INFECTION. WITH VITALS BACK TO NORMAL, THE PATIENT WAS TRANSFERRED TO THIS FACILITY, WHERE A THOROUGH EXAMINATION WAS CONDUCTED AND INFECTION WAS CONFIRMED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE ALL THE IMPLANTS AND PLACE THE ANTIBIOTIC CEMENT MOLD. ALSO, DRAINS WERE PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE INFECTION WAS CAUSED BY PUS THAT HAD ACCUMULATED IN THE TOE. HISTORY OF DIABETES MELLITUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Dizziness; Sepsis; Unspecified Infection

  MAUDE report 16752411 ↗
• MalfunctionApr 30, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SCREW THAT SHOULD FIX THE AUGMENT TO THE FEMORAL COMPONENT DID NOT SINK IN THE AUGMENT'S HOLE, BUT PROTRUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757312 ↗