ATTUNE LPS 1517-60-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295491033), received between Jul 1, 2020 and Aug 20, 2025 — classified as 5 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 15, 2023Class IIOpen, Classified

   The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

   Z-1265-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

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.

• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22853689 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WASH OUT OF THE KNEE AND THE SURGEON EXCHANGED THE POLY BECAUSE PATIENT HAS AN INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22383713 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: PAIN.

  Patient problems: Pain

  MAUDE report 18958914 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14218701 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE KNEE. THE PATIENT UNDERGO IRRIGATION AND DEBRIDEMENT AND REPLACEMENT OF TIBIAL INSERT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10217885 ↗