ATTUNE 1504-11-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295041931), received between Nov 21, 2018 and Jan 5, 2026 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE, ALL COMPONENTS REMOVED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23960012 ↗
• MalfunctionSep 5, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  THE FEMORAL COMPONENT WAS NOTICED TO BE SCRATCHED AFTER IT WAS IMPLANTED IN THE PATIENT. IT DID NOT APPEAR TO HAVE BEEN DAMAGED BY THE IMPACTOR (NO DAMAGE COULD BE SEEN ON THE IMPACTOR). IT IS BELIEVED THAT THIS SCRATCH MAY HAVE BEEN A MANUFACTURING ERROR. WAS HAPPY TO STILL USE THE FEMUR AND DIDN'T WANT TO OPEN ANOTHER ONE.

  Patient problems: Insufficient Information

  MAUDE report 20143955 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INCREASING PAIN, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. REPLACED WITH ALL REVISION COMPONENTS. NO INSTRUMENTS WERE BROKEN IN THE CASE, THEREFORE, NO BROKEN INSTRUMENTS REMOVED FROM THE PATIENT. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13237544 ↗
• MalfunctionJul 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON COMPLAINS ABOUT FEMUR BEING VERY HARD TO SEAT/IMPLANT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215134 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO PAIN. DOI: UNK, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11995459 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN LEFT KNEE AFTER TOTAL KNEE ARTHROPLASTY DUE TO OVERACTIVITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020 (LEFT KNEE). TREATMENT - DIAGNOSTIC INTERVENTION: BONE SCINTIGRAPHY (NUCLEAR MEDICINE STUDY-INVASIVE) RESULTS: NORMAL.

  Patient problems: No Code Available; Pain

  MAUDE report 10727381 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS LEFT KNEE EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019; (LEFT KNEE).

  Patient problems: Fibrosis

  MAUDE report 8990938 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CEMENTLESS TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018. POST OP DAY ONE DEVELOPED POSITIVE CULTURES FOR INFECTION. PATIENT WAS BROUGHT BACK TO OR FOR ONE STAGE EXPLANT OF KNEE COMPONENTS & REVISION TOTAL KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 8094673 ↗