ATTUNE 1518-20-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295541912), received between Dec 27, 2022 and Feb 6, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OR REMOVAL PROCEDURE DUE TO INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24280069 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE OR WITH OPEN WOUND DRAINING. THE DR. DISSECTED DOWN, FOUND OUT THAT IT WENT TO THE JOINT SPACE. THE DR. DECIDED TO CHANGE OUT THE INSERT. NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING. DOI: UNKNOWN. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 23707070 ↗
• MalfunctionNov 24, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR FOUND INSIDE THE FIRST LAYER OF STERILE PACKAGING FOR THE IMPLANT DEVICE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632873 ↗
• MalfunctionOct 9, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024, THE TIBIAL INSERT WOULD NOT SEAT ON THE LATERAL SIDE OF THE TIBIA TRAY. IT WAS NOTED THERE WAS NO PATIENT CONSEQUENCE DUE TO THIS EVENT. DOI:(B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE : LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408456 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REPEATED SWELLING IN KNEE. SYNOVECTOMY AND EXPLORATION. IMPLANTS WERE NOT LOOSE. POLY WAS EXCHANGED. THERE WAS NO DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 18934534 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO CHRONIC EFFUSION. DATE OF IMPLANT: (B)(6) 2023; DATE OF REVISION: (B)(6) 2024; (LEFT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Swelling/ Edema

  MAUDE report 18926633 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY SWAP FOR POSSIBLE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18757276 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LARGE EFFUSION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: 10 JAN 2024. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 18555538 ↗
• MalfunctionJan 2, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT THERE WERE NO STICKERS ON THE IMPLANT OR IN THE BOX OF THE SIZE 8 X 8MM LEFT MS INSERT. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428671 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SINGLE STAGE REVISION FOR AN ACUTE INFECTION. ATTUNE IMPLANTS WERE REMOVED, WOUND I&D, AND NEW ATTUNE IMPLANTS WERE USED. IMPLANTS ARE UNAVAILABLE FOR RETURN AND THERE WAS NO DELAY IN THE PROCEDURE. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17736121 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (LEFT KNEE). TREATMENT: ASPIRATION; 20 CC OF BLOOD ASPIRATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16742385 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LTK ON (B)(6) 2022, JUST SEVERAL DAYS AGO. HE HAS AN ATTUNE FIXED BEARING, MEDIAL STABILIZED CONSTRUCT WITH AFFIXIUM TIBIA. HE IS INFECTED. HE IS BEING REVISED FOR THE CONFIRMED INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND THE POLY WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16051311 ↗