ATTUNE 1504-01-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295041320), received between Aug 11, 2020 and Apr 20, 2026 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION TO TREAT INSTABILITY AND PAIN. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24926070 ↗
• MalfunctionApr 4, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE ATTUNE CEMENTLESS CR SIZE 3 LEFT FEMORAL COMPONENT POROCOAT COATING FAULTY. THE POROCOAT COATING HAD VISIBLE CRACKING ON THE ANTERIOR CHAMFER REGION. SURGEON NOTICED THE DEFECT AND IT WAS NOT IMPLANTED. SURGERY WAS DELAYED 3 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039890 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12541181 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 BY IMPLANTING THE FEMORAL COMPONENT, THE TIBIAL TRAY, THE TIBIAL INSERT FOR THE PATIENT¿S LEFT KNEE JOINT. AFTER THE SURGERY, THE PATIENT SPRAINED HER ANKLE JOINT ON (B)(6) 2020 (THIS EVENT WAS REPORTED AS (B)(4)). IT WAS REPORTED THAT THE PATIENT HAD CHEST PAIN ON (B)(6) 2019, AND SHE WAS ADVISED EXAM BY PRIMARY CARE DOCTOR. THEN, SHE UNDERWENT CAG UNDER HOSPITALIZATION ON (B)(6) 2020 AT (B)(6) HOSPITAL, AND SHE WAS ADMITTED INTO THE HOSPITAL FROM (B)(6) 2020 TO (B)(6) 2020. SHE HAS NO SYMPTOM NOW AND IS IN TREATMENT WITH MEDICATION.

  Patient problems: Chest Pain; No Code Available

  MAUDE report 10393302 ↗