ATTUNE 1518-20-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 308 adverse event reports that list this exact device (DI 10603295056706), received between Jul 7, 2017 and Jul 15, 2026 — classified as 298 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (21 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 308 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 25828353 ↗
• InjuryJul 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BIPARTITE PATELLA. THIS LEAD TO PATELLA FAILURE AND CLUNK. OLD PATELLA WAS SAWN OFF AND MOVE INFERIOR AND ROTATED SLIGHTLY TO LESSEN THE AMOUNT OF OVER HANG ON THE BIPARTITE PATELLA. THE MOST SUPERIOR PORTION OF THE PATELLA WAS HOLLOWED OUT TO ALLOW IT TO MOVE AND NOT HIT THE PATELLA. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25814860 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25779719 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE INFECTION. INSERTION FOR SPACER. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25642027 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING AND INFECTION. THERE WAS LOOSENING OF THE FEMUR AND TIBIA. THE CEMENT MANUFACTURER WAS UNKNOWN. NO LOT NUMBERS ARE AVAILABLE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25395102 ↗
• InjuryFeb 3, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATELLA WAS LOOSE AND UNSTABLE. NEW PATELLA AND V/V CONSTRAINING INSERT.

  Patient problems: Joint Laxity

  MAUDE report 24244471 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN . DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24178254 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AND A STAGE 1 KNEE REVISION. THEY PUT IN A TEMPORARY ANTIBIOTIC SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24053399 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE. NO OTHER INFORMATION WAS KNOWN. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Septic loosening

  MAUDE report 23841828 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23821672 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SEPTIC REVISION IN RIGHT KNEE. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 23721158 ↗
• InjuryNov 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSE PATELLA. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE

  Patient problems: Insufficient Information

  MAUDE report 23657865 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23654000 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PLACED. THERE WERE NO DELAYS OR PATIENT INJURY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23560220 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 15 FEB 2020. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: 2 X ERYTHROCYTE CONCENTRATE.

  Patient problems: Anemia

  MAUDE report 23368127 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH GROSS INFECTION WITH A DRAINING SINUS POST TKA. ALL COMPONENTS WERE REMOVED AND A THOROUGH I&D WAS PERFORMED AND A STATIC SPACER FASHIONED UTILIZING LPS COMPONENTS COATED WITH HIGH DOSE ANTIBIOTIC CEMENT. RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN THE FEMORAL AND TIBIAL CANALS ALONG WITH THE GUTTERS. THERE WAS NO DELAY NOR WAS ANY PATENT HARM NOTED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23300570 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ALL IMPLANTS WERE EXPLANTED AND SPACER WAS IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23075826 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON DECIDED TO PUT IN A THICKER POLY AND PUT IN A NEW PATELLA TO HELP WITH TRACKING. NO MENTIONED ANYTHING WRONG WITH THE IMPLANTS. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23031898 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT NOT LOOSE, JUST NOT INGROWN. NOT THE SAME THING.

  Patient problems: Unspecified Infection

  MAUDE report 22872967 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. AFTER ENTERING THE JOINT, THE PATELLA COMPONENT HAD FAILED AT THE BONE/CEMENT INTERFACE AND WAS FLOATING IN THE JOINT. COMPONENTS SHOWED SIGNS OF LOOSENING ON A BONE SCAN. COMPONENTS WERE REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22641949 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INCISION AND DRAINAGE WITH POLY EXCHANGE ON (B)(6) 2023 AS WELL AND HAD BEEN FIGHTING DRAINAGE. SURGEON ELECTED TO REMOVE AND PLACE A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22555428 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS A STAGE 1 KNEE REVISION. SURGEON TOOK OUT ALL COMPONENTS AND PUT IN AN ANTIBIOTIC SPACER TO RULE OUT INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22522481 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED BY THE SURGEON. THERE WAS NO DELAYS IN SURGERY OR ANY PATIENT INJURY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22496773 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IS REVISING DUE TO KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22321285 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SEPTIC MOBILIZATION OF RIGHT KNEE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22204569 ↗