ATTUNE 1520-20-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295542728), received between Feb 16, 2023 and Jun 26, 2026 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSERT REVISION FOR INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25634866 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SEPTIC WASHOUT AND INSERT CHANGE DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24191002 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT AND LINER WERE EXCHANGED. THERE WAS NO DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23837076 ↗
• 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 INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23645168 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE WITH WASHOUT WAS DONE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22796164 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THEY WERE EXPERIENCING STIFF KNEE PAIN SINCE ORIGINAL SURGERY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 22029579 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. SURGEON EXPLANTED PRESS FIT PRIMARY IMPLANTS AND PLACED CEMENTED PRIMARY IMPLANTS AFTER IRRIGATION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21746498 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 21376930 ↗
• MalfunctionJan 3, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE OUTER PACKAGE WAS DAMAGED AND PUNCTURED THE INNER FILM LAYER OF THE STERILE IMPLANT. THE SECONDARY SEAL INSIDE THE CARDBOARD BOX PUNCTURED MAKING THE IMPLANT NO LONGER STERILE TO USE. THE BOX MUST HAVE BEEN SLIGHTLY CRUSHED OR HIT AGAINST SOMETHING IN TRANSPORT. NOT SURE IF IT HAPPENED DURING THE CASE OR DURING ANOTHER SURGERY EARLIER THIS WEEK. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21067300 ↗
• MalfunctionDec 3, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN IMPLANTED, MS INSERT WAS SITTING PROWLED ON THE MEDIAL SIDE. POLY WAS IMPACTED YET STILL HAD NOTICEABLE SPACE BETWEEN IT AND BASEPLATE. IT WAS NOT CAPABLE OF PROPERLY SEATING AND LOCKING INTO THE TIBIAL TRAY. THE PATIENT WAS UNAFFECTED, AS ANOTHER MS INSERT WAS OPENED TO REPLACE THE DEFECTIVE ONE. THERE WAS A DELAY OF FIVE MINUTES. DOI: (B)(6) 2024. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831721 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO INFECTION. SURGEON WASHED IT OUT AND CHANGED THE POLY. DATE OF IMPLANT WAS (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20751561 ↗
• MalfunctionNov 13, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED, THAT THE PATIENT'S POLY WAS DAMAGED, WHILE TRYING TO IMPACT INTO BASEPLATE. THE FRONT OF THE IMPLANT, WHERE IT SNAPS INTO THE BASE PLATE WAS BENT FROM THE IMPACTION HANDLE, WHILE ATTEMPTING TO IMPACT IT. THE IMPLANTS WERE NOT FITTING TOGETHER PROPERLY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20677857 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HEMATOMA. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 18816662 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023; DOR:(B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18796748 ↗
• MalfunctionJan 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING TKR, THE SURGEON MADE AN ATTEMPT TO PLACE THE FINAL INSERT IN THE PATIENT AND WAS UNABLE TO GET THE INSERT TO ENGAGE IN THE FIX BEARING TRAY. THE INSERT WAS THEN REMOVED AND A NEW INSERT WAS SUCCESSFULLY PLACED IN THE TOTAL KNEE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, IF YES, NUMBER OF MINUTES: 0, ACTION TAKEN WHEN EVENT OCCURRED? THE INSERT WAS REMOVED. A NEW INSERT WAS OPENED AND SUCCESSFULLY PLACED IN PATIENT WITH NO DELAY., WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? THERE WAS NO CLINICAL OUTCOME EXPERIENCED BY THE PATIENT., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IF YES, DESCRIBE NO ADDITIONAL MEDICAL INTERVENTIONS NEEDED. , IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605755 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS KNEE WAS INFECTED SO SURGEON WENT BACK IN, IRRIGATED IT AND PUT A NEW POLY IN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16385646 ↗