ATTUNE 1504-01-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295041412), received between Jul 26, 2023 and Jan 16, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT KNEE WAS INFECTED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24099275 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR PINS AND NEEDLES L KNEE AND LIMITED ROM. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE) (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Loss of Range of Motion; Paresthesia

  MAUDE report 17488384 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AN IMPLANT SURGERY WAS PERFORMED VIA TKA FOR OA IN BOTH KNEES. ON (B)(6) 2023, THE PATIENT CAME TO THE HOSPITAL DUE TO SWELLING IN THE LEFT KNEE. THE REASON FOR THE INFECTION AND THE EVENT DATE ARE UNKNOWN. THE SURGERY FOR LEFT KNEE CLEANING IS SCHEDULED FOR (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 17397164 ↗