ATTUNE 1504-11-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295041917), received between Jan 10, 2020 and Sep 2, 2025 — classified as 8 injuries, 3 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. TIBIAL BASEPLATE AND FEMORAL COMPONENT WERE LOOSE AT NON-CEMENTED INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22939222 ↗
• InjurySep 6, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20157208 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18038050 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13043397 ↗
• MalfunctionAug 19, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT SURGERY TIME WAS EXTENDED BY APPROXIMATELY 5-10 MINUTES. THE CEMENTLESS FEMUR WAS REMOVED WITH THE INTRODUCER AND A CEMENTED FEMUR WAS OPENED IMMEDIATELY. CEMENT WAS ALREADY MIXED FOR THE PATELLAR COMPONENT AND THE EXCESS AVAILABLE ON THE FIELD WAS UTILIZED TO APPLY TO THE FEMORAL COMPONENT RESULTING IN MINIMAL EXTENSION TO THE TOTAL SURGERY TIME.

  Patient problems: Insufficient Information

  MAUDE report 12341591 ↗
• MalfunctionJul 27, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DOCTOR'S LAST 3 ATTUNE PRESSFIT FEMURS HAVE BEEN VERY DIFFICULT TO IMPLANT/SEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235105 ↗
• MalfunctionJul 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FEMUR WAS BEING VERY HARD TO SEAT/IMPLANT ON PATIENT. NO SURGICAL DELAY. DOE: (B)(6) 2021. LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215152 ↗
• InjuryJan 4, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PATELLAR CLUNK SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: ARTHROSCOPY WITH SYNOVECTOMY; PRESCRIBED A HINGED KNEE BRACE.

  Patient problems: Insufficient Information

  MAUDE report 11108221 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXISTING HYDROPS (EDEMA) 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 (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION - INVASIVE KNEE ASPIRATION FOR CULTURES TO RULE-OUT POSSIBLE INFECTION : RESULTS WERE NEGATIVE FOR INFECTION; MEDICAL TREATMENT - LEFT KNEE BRACE.

  Patient problems: Edema; No Code Available

  MAUDE report 10690386 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR HEMATOMA ON THE LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA AND PUNCTURE.

  Patient problems: Hematoma

  MAUDE report 9831199 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OEDEMA LOWER LEGS 13 DAYS AFTER SURGERY FOR TKP. 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: (B)(6) 2019, (LEFT KNEE).

  Patient problems: Adhesion(s); Edema; No Code Available

  MAUDE report 9574838 ↗