ATTUNE 1518-20-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295541820), received between Apr 26, 2023 and Mar 16, 2026 — classified as 16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

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

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. I&D FOR POLYS WAS PERFORMED. THERE IS NO WAY TO CONFIRM INFECTION AND THERE IS NO ALLEGATION AGAINST IMPLANT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24605992 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, LEADING TO THE REMOVAL AND REPLACEMENT OF THE DEVICE. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24506565 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO INSERT EXCHANGE DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24072763 ↗
• MalfunctionJan 14, 2026Difficult to Insert

  IT WAS REPORTED THAT THE MS POLY DID NOT SEAT PROPERLY DURING IMPLANTATION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071114 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE INFECTION. INCISION AND DRAINAGE WITH LINER EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24059246 ↗
• InjuryNov 25, 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 TKA. PATIENT NOW NEEDED MORE STABILITY. A 7-7 WAS REMOVED AND A 7-12 IMPLANTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23644049 ↗
• 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 23560217 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION OF TOTAL KNEE. KNEE WAS WASHED OUT AND LINER WAS EXCHANGED. THERE WAS NO PATIENT INJURY OR DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23037443 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LINER EXCHANGE TO RULE OUT INFECTION. IT IS UNKNOWN IF INFECTION WAS CONFIRMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23015048 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22284446 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22234271 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR THE SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT OR NOT. ONLY THE TIBIAL INSERT POLYETHYLENE WAS REMOVED AND REPLACED IN CONJUNCTION WITH WASHOUT. NO OTHER INFORMATION IS KNOWN. NO ADDITIONAL SURGICAL DELAYS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21880912 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL 4 DAYS POST-OP AND OPENED INCISION. THE SURGEON WASHED OUT AND REPLACED TIBIAL LINER. THERE WAS NO ADDITIONAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 21688235 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE HAVE BEEN 3 REVISIONS IN THE ATTUNE MS COHORT. 1 EACH FOR INFECTION, INSTABILITY, AND ASEPTIC MECHANICAL LOOSENING. ATTUNE MS REVISION RATE AT INSTITUTION IS 0.4%.

  Patient problems: Joint Laxity

  MAUDE report 21314382 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL PRIMARY COMPONENTS WERE REMOVED DUE TO INFECTION & SOFT TISSUE DAMAGE FROM THE PATIENT FALLING. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20623312 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A I/D WASH OUT WITH POLY SWAP FOR INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17828794 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023. (LEFT KNEE) TREATMENT: BLOOD GIVEN; PANTOPRAZOLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16815323 ↗