ATTUNE 1511-01-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295436508), received between Oct 1, 2019 and Mar 25, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT PRESENTED WITH AN LPS STATIC SPACER POST INFECTION THAT HAD DISASSOCIATED. THIS IS AN UNUSUAL OCCURRENCE AS SURGEON UTILIZES THESE COMPONENTS REGULARLY FOR THIS INDICATION. INFECTION HAS CLEARED AND SEGMENTS AND COMPONENTS ON TIBIAL SIDE WERE REMOVED TO PLACE AN LPS DISTAL FEMORAL REVISION TKA. ALL COMPONENTS WERE WELL FIXED. CEMENT UTILIZED FOR THE SPACER WAS HOSPITAL OWNED SO NO LOT NOR QUANTITY INFORMATION IS AVAILABLE IN OUT RECORDS. NO DELAY NOR PATIENT HARM WAS NOTED. DOI - (B)(6) 2026. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691108 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVE X-RAYS SHOWED A FEMUR FRACTURE. SURGEON DECIDED TO REMOVE IMPLANTS AND REDUCE FRACTURE/REPOSITION KNEE REVISION. NO COMPLAINTS ABOUT INSTRUMENTATION OR IMPLANTS AND THERE WAS NO DELAY TO SURGERY TIME. THE FEMORAL BONE FRACTURED, THE IMPLANT WAS INTACT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22034580 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FROM NEXGEN TO ATTUNE REVISION ON (B)(6) 2020. HAS PRESENTED WITH INSTABILITY AND X-RAY SHOWS THE TIBIA HAS SUBSIDED. CONCERNED WITH INTEGRITY OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS THE PATIENT HAS HAD KNEE REVISED ONCE AGAIN FOR A HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20051741 ↗
• InjuryMar 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL LOOSENING OF THE STUDY KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: 30 AUG 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL DISTAL AUGMENT, FEMORAL POSTERIOR AUGMENT, AND TIBIAL INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18844620 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT ANKLE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2022. RIGHT KNEE. TREATMENT: INJECTED MEDICATION.

  Patient problems: Pain

  MAUDE report 15012667 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF IMPLANT. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF REVISION: (B)(6) 2020; (UNKNOWN KNEE). TREATMENT: REMOVAL OF IMPLANT FOR UNKNOWN REASON.

  Patient problems: Unspecified Infection

  MAUDE report 14680526 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION - MANIPULATION OF RIGHT KNEE UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 11633693 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. A COMPETITOR CEMENT WAS USED. INTERNAL LEFT KNEE PROSTHESIS WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11114367 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TOTAL KNEE HAD BEEN REVISED ON (B)(6) 2019 FOR INFECTION. PATIENT HAD NEVER FOLLOWED UP AFTER SURGERY AND CAME BACK TO SEE WITH A PAINFUL KNEE. SURGEON WORKED HER UP AND FOUND OUT PATIENT HAD ANOTHER INFECTION AND DECIDED TO REMOVED KNEE IMPLANTS. SURGEON REMOVED ALL THE IMPLANTS WITH NO PROBLEMS AND DID A WASHOUT OF THE KNEE. REPLACED WITH AN ANTIBIOTIC CEMENT SPACER. SURGEON HAD NO DIFFICULTIES REMOVING THE IMPLANTS AND TIME WAS NOT EXTENDED FOR ANY REASON. DOI: (B)(6) 2019 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10312193 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF COMPONENTS DUE TO INFECTION, ALL COMPONENTS REMOVED FROM PREVIOUS REVISION CASE DONE ON THE (B)(6) 2020 WHICH WAS THE 2ND STAGE REVISION, 1ST STAGE REVISION COMPLETED ON THE (B)(6) 2019. PRIMARY SURGEON //NAME: (B)(6), PRIMARY SURGERY FACILITY: (B)(6), THIS IS THE 3RD STAGE REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853001 ↗
• InjuryOct 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT IS HAVING A LEFT TOTAL KNEE REVISION WITH A COMPETITOR PRODUCT IMPLANTED. THE ATTUNE REVISION TRIALS WERE ALL SAT PERFECTLY DURING TRIALING. DURING THE IMPLANTATION OF THE DEFINITIVE COMPONENTS, THE FEMORAL COMPONENT WOULD NOT SEAT FULLY. IT WAS LEFT PROUD AND CREATED A GAP BALANCE ISSUE. ALSO DURING IMPACTION OF THE REAL FEMUR, THE ANTERIOR CORTEX OF THE FEMUR CRACKED. THE STEM WAS OVER-REAMED BY 1MM. THE BROACH AND THE FEMORAL TRIAL CONSTRUCT SAT PERFECTLY. THERE WAS A 3 MINUTES SURGICAL DELAY. DOE: (B)(6) 2019 LEFT KNEE

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9139158 ↗