ATTUNE 1520-20-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295542421), received between May 1, 2024 and Jul 21, 2026 — classified as 5 injuries.

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

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE. SURGEON UPSIZED POLY AND WAS SATISFIED WITH STABILITY. THERE WERE NO DELAYS OR COMPLAINTS. NO HARM TO PATIENT. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 25893167 ↗
• InjuryJun 20, 2025Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR A KNEE REVISION HAS BEEN REPORTED WITH POTENTIAL REMOVAL OF DEPUY COMPONENTS. (B)(6) 2023, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. (B)(6) 2025 THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OTHER MECHANICAL COMPLICATION OF INTERNAL RIGHT KNEE PROSTHESIS. INDICATIONS FOR SURGERY INCLUDED INTERMITTENT SNAPPING LOCKING AND PAIN. PREOPERATIVE RADIOGRAPHS WERE REPORTED TO SUGGEST THAT THE POLYETHYLENE HAD DISSOCIATED FROM THE METAL BASE. DURING THE PROCEDURE, THE SURGEON OBSERVED YELLOW EFFUSION, CHRONIC SYNOVITIS. OPERATIVE NOTES STATE THAT IT WAS IMPOSSIBLE TO DETERMINE IF THE LOCKING MECHANISM WAS COMPROMISED OR NOT AND WHETHER THE TIBIAL COMPONENT HAD ACTUALLY BEEN ROCKING IN AND OUT OF THE BASE PLATE.

  Patient problems: Insufficient Information; Pain; Swelling/ Edema; Synovitis

  MAUDE report 22299399 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21738116 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21409838 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE SURGEON NEEDED TO SWAP THE POLY TO ADDRESS A HEMATOMA. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 19222526 ↗