ATTUNE 1504-01-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295041566), received between Oct 14, 2020 and Apr 8, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Migration

  IT WAS REPORTED THAT THE KNEE FELL INTO VALGUS, AND THE SURGEON THINKS THE LATERAL CONDYLE MICRO-FRACTURED DURING THE PRIMARY PROCEDURE. NO ISSUES WERE NOTED WITH THE IMPLANTS OR INSTRUMENTS. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24815134 ↗
• MalfunctionFeb 17, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A PIECE OF RUBBER PACKAGED WITH THE IMPLANT. IT LOOKED LIKE A PIECE OF PLASTIC FROM A GLOVE. DOCTOR DID NOT KNOW IF IT WAS STERILE SO DR. CHOSE NOT TO USE IT. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364641 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REVISION RTKA. PATIENT FELL SEVERAL MONTHS AGO AND HAS PAINFUL KNEE. THE TIBIA IMPLANT WAS COMPACTED DOWN MEDICALLY. REMOVED THE FEMORAL IMPLANT, TIBIAL IMPLANT AND INSERT. REVISED WITH ATTUNE REVISION KNEE SYSTEM. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 20200576 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17058586 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, SWELLING, AND INSTABILITY, WITH LOOSENING OF IMPLANT, RIGHT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) /2019; (RIGHT KNEE). TREATMENT: MEDICAL INTERVENTION - ANALGESICS; DIAGNOSTIC INTERVENTIONS - CT, SCINTIGRAPHY (INVASIVE-RADIOISOTOPES INJECTED), ULTRASOUND; PHYSICAL THERAPY; REVISION SURGERY ON (B)(6) 2020 WITH EXPLANTATION OF STUDY KNEE. PATELLA WAS NOT RESURFACED DURING PRIMARY

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10679329 ↗