ATTUNE 1504-10-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295041733), received between Sep 17, 2018 and Feb 26, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 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.

• InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA FOR OA FOR THE RIGHT KNEE JOINT WITH THE IMPLANTS IN QUESTION. ON (B)(6) 2023, IT WAS CONFIRMED THAT THERE WAS A STRANGE NOISE NEAR THE PATELLA IN THE ANTERIOR REGION. THEREFORE, ON (B)(6) 2024, ONLY PATELLA REPLACEMENT WAS PERFORMED. SINCE A PRIMARY TKA OF THE LEFT SIDE WAS ALSO SCHEDULED TO BE PERFORMED IN THIS SURGERY, THE LEFT SIDE WAS PERFORMED FIRST AND WAS COMPLETED WITHOUT PROBLEMS. SUBSEQUENTLY, A PROCEDURE WAS PERFORMED TO REPLACE THE PATERA (29MM:151820029) ON THE RIGHT SIDE AND REDUCE THE THICKNESS OF THE PF. PF TRACKING AFTER REPLACEMENT WAS RELATIVELY GOOD.

  Patient problems: Insufficient Information

  MAUDE report 18778124 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE CAUSE OF THE INFECTION WAS AN ABRASION ON THE FOOT THAT WAS LEFT UNTREATED AND BECAME SWOLLEN. THE TREATMENT FOR INFECTION WAS REMOVAL OF THE IMPLANTS AND PLACEMENT OF AN ANTIBIOTIC CEMENT MOLD. THE PATERA WAS NOT EXTRACTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16752789 ↗
• InjuryNov 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8091266 ↗
• InjurySep 17, 2018Migration; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT FEMORAL HAD SUBSIDED LATERALLY. NO TRAUMA PER PATIENT. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Bone Fracture(s); Deformity/ Disfigurement; Not Applicable; Pain

  MAUDE report 7880532 ↗