ATTUNE 1504-01-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295041474), received between Dec 22, 2020 and Aug 17, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient was revised due to instability.Affected side: Right Knee

  Patient problems: Joint Laxity

  MAUDE report 50275454 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED FOR TIBIAL PAIN AND WANTED IMPLANTS REMOVED AND REVISED. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24800725 ↗
• InjuryJul 10, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. 2. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? REQUIRED REVISION SURGERY DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19709202 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18658684 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERGOES A RIGHT TOTAL KNEE ARTHROPLASTY INCLUDING PATELLA RESURFACING AND USE OF DEPUY SYNTHES BONE CEMENT. THERE ARE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT WAS REVISED DUE TO SYMPTOMS OF PAIN, BURNING, AND INSTABILITY WITH XRAY SUGGESTION THAT THERE WAS LIKELY A POLY SPINOUT. INTRAOPERATIVE FINDINGS WERE THAT THE EXTENSOR MECHANISM WAS EXTREMELY POOR AT THE QUADRICEPS TENDON DUE TO THE PATIENT RECENTLY BEING OPERATED ON. THE POLY WAS CONFIRMED TO HAVE SPUN OUT. ALL COMPONENTS WERE REMOVED WITH EXCEPTION OF THE PATELLA AND AN SROM HINGED CONSTRUCT WAS PLACED. THE SROM HINGE WAS SELECTED AS THE PATIENT WOULD HAVE REQUIRED TOO LARGE OF A POLY INSERT TO CAUSE PATELLA BAJA. THERE WERE NO FURTHER COMPLICATIONS NOTED AFTER THE REVISION. DOI:(B)(6) 2021; DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18250796 ↗
• MalfunctionSep 5, 2023Off-Label Use; Manufacturing, Packaging or Shipping Problem; Off-Label Use; Manufacturing, Packaging or Shipping Problem

  PRODUCT HAS BEEN RECALLED BY J&J DUE TO WRONG IMPLANT SIZE BEING IN THE BOX, THE SURGEON CONFIRMED YESTERDAY THAT THIS AFFECTED IMPLANT HAS BEEN IMPLANTED INTO A PATIENT. SIGNED FIELD SAFETY NOTICE RECEIVED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684211 ↗
• MalfunctionApr 12, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT SURGEON DID A CEMENTLESS ATTUNE KNEE THIS MORNING AND CUT A SIZE 4R A SIZE 4 FEMUR WAS OPENED AND IMPLANTED. DESPITE BEING PACKAGED AS SIZE 4, APPEARED TO HAVE THE DIMENSIONS OF A SIZE 5 FEMUR EXTERNALLY. THIS WAS NOTICED AS THE PROSTHESIS OVERHUNG AND WHEN MEASURING WITH A CALIPER SEEMS TO BE A SIZE 5 ON THE OUTER DIMENSIONS. WE WERE UNABLE TO MEASURE INTERNAL DIMENSIONS. THE FEMUR WAS ALSO LOOSE AFTER IMPLANTATION PUT IT ON. WHEN THE IMPLANT WAS REMOVED, IT IS LABELLED AS A 4R. THE SURGEON HAD TO IMPLANT A 4N INSTEAD WHICH FITTED CORRECTLY AND WAS SECURE. THE SURGEON WAS HAPPY WITH THE SIZING ON THE M/L OF THE PROSTHESIS, HOWEVER WOULD NOT HAVE BEEN ABLE TO IMPLANT A SIZE 4R AS ONLY ONE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723563 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2021. RIGHT KNEE. TREATMENT: REVISION; FEMORAL, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 15751189 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017. DATE OF EVENT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. RIGHT KNEE. TREATMENT: REMOVAL OF FEMORAL COMPONENT, TIBIAL BASE, AND TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 14929609 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT WAS EXPERIENCING SOME ANTERIOR PAIN AND MAY HAVE A FLEXION CONTRACTURE. HE THEN PREPPED THE NATIVE PATELLA AND CONVERTED THE KNEE FROM A CS TO A PS KNEE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Joint Contracture; Pain

  MAUDE report 11058310 ↗