ATTUNE 1547-07-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295382836), received between May 7, 2021 and Jul 27, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient contracted MRSA, all implants removed and replaced with antibiotic spacer. DOI: Unknown.DOR: Unknown. Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50039279 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED DUE TO INFECTION AND WASH OUT. THERE WAS NO HARM DONE TO THE PT. NOR DELAY TO THE CASE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25042424 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED DUE TO INFECTION AND WASH OUT. THERE WAS NO HARM DONE TO THE PT. NOR DELAY TO THE CASE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25042264 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGEON EXPLANTED FEMUR AND REVISED WITH TEMPORARY SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16184593 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POLY SPIN OUT DUE TO THE GAP BETWEEN THE FEMUR AND TIBIA BEING TOO LARGE. SURGEON IMPLANTED A HINGE WITH THICK TRAY TO CLOSE THE JOINT SPACE. NO SURGICAL DELAY HAS BEEN REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11791174 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POLY SPIN OUT DUE TO THE GAP BETWEEN THE FEMUR AND TIBIA BEING TOO LARGE. SURGEON IMPLANTED A HINGE WITH THICK TRAY TO CLOSE THE JOINT SPACE. NO SURGICAL DELAY HAS BEEN REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11791148 ↗