ATTUNE LPS 1517-60-612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295490760), received between Jun 22, 2022 and Oct 9, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17898458 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HINGED KNEE PLACED STATUS POST KNEE SPACER ON 5-19. PATIENT CAME BACK TO HOSPITAL WITH A WARM RED KNEE. SURGEON BELIEVED INFECTION WAS STILL PRESENT AND ALL COMPONENTS WERE REMOVED AND NEW SPACER WAS FASHIONED UTILIZING LPS COMPONENTS AS THE MCL WAS FOUND TO BE INCOMPETENT AT THE TIME OF SURGERY ON 5-19. A DUAL SET WAS UTILIZED AND ANTIBIOTIC BEADS WERE PLACED ALONG WITH HIGH DOES ANTIBIOTIC CEMENT. CEMENT IS DEPUY 2 WITH GENT BUT LOT IS UNAVAILABLE AS IT IS HOSPITAL OWNED INVENTORY. DUE TO SHORT DURATION OF IMPLANTATION AND SUSPECTED INFECTION, NEITHER SLEEVE WAS INGROWN AT TIME OF REMOVAL. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14773902 ↗