ATTUNE 1520-20-607Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295542582), received between Jan 30, 2023 and Jul 6, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

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

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

  Patient problems: Pain

  MAUDE report 25721207 ↗
• MalfunctionFeb 8, 2026Difficult to Insert

  IT WAS REPORTED THAT INSERT DID NOT SEAT PROPERLY INTO THE TRAY. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288448 ↗
• InjuryNov 12, 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 POLY EXCHANGE AND WASH OUT FOR INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23535651 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL ONE DAY POST-OP WHILE USING THE BATHROOM AFTER A RTKA AND DISLOCATED THEIR FEMUR POSTERIOR TO THE TIBIA. ALL COMPONENTS REMOVED AND PATIENT WAS CONVERTED TO AN SROM HINGE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23004056 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH LINER EXCHANGE TO RULE OUT INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21137254 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS THERE ANY PATIENT CONSEQUENCE/S RELATED TO THE EVENT? NO.

  Patient problems: Unspecified Infection

  MAUDE report 21111399 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS.

  Patient problems: Joint Laxity

  MAUDE report 19058364 ↗
• MalfunctionOct 23, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT WHEN PRODUCTS WERE OPENED THE INNER PLASTIC CONTAINER HAD A HOLE THROUGH IT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(6). DEVICE PROPERTY OF, NONE, DEVICE IN POSSESSION OF, NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17989927 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S INCISION WAS OPENED DUE TO FALL. DOCTOR SWAPPED THE POLY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16264796 ↗