ATTUNE LPS 1517-60-114Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295491071), received between Sep 11, 2020 and Apr 14, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH POSSIBLE INFECTION; SURGEON ELECTED WASH OUT AND CHANGE OF MODULAR COMPONENTS. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24873292 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH SOME LAXITY POST REVISION TKA ON THE ABOVE LISTED DATE. THE SURGEON DID NOTE SOME PATELLAR MALTRACKING VIA X-RAY. THE SURGEON CHOSE TO EXCHANGE COMPONENTS TO ADDRESS LAXITY AND INCREASE EXTERNAL ROTATION OF THE FEMORAL COMPONENT. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS. THERE WAS NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24672944 ↗
• InjuryOct 24, 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 INFECTION. THE SURGEON PERFORMED I&D AND HAD AN INSERT SWAP. THE SURGERY TIME WAS NOT EXTENDED. THERE WAS NO ALLEGED DEFICIENCY WITH THE PRODUCT. THERE WAS NO INSTRUMENT BREAKAGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23377793 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISED OF POLY SWAP FOR POSSIBLE INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22393776 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION ON A DISTAL FEMUR DUE TO PATELLA INSTABILITY. PATELLA WAS NATURAL AND WAS NOT RESURFACED OR REVISED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22071137 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOSS OF FIXATION TO THE OSTEOTOMY IS WHAT LED TO THE POOR PATELLAR TRACKING. IMPLANTS WERE PERFORMING AS EXPECTED.

  Patient problems: Joint Laxity

  MAUDE report 22021587 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSERT EXCHANGED FOR THICKER INSERT. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20705399 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 19286539 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. (B)(4) ARE RELATED TO EACH OTHER.

  Patient problems: Physical Asymmetry

  MAUDE report 19033839 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE LOOSENING INVOLVED IN THE EVENT? IF YES, PLEASE PROVIDE THE LOOSENING COMPONENT/S. -YES AND AS STATED IN THE DER, THERE WAS LOOSENING AT BOTH THE BONE/SLEEVE AND BONE/STEM INTERFACE MIST LIKELY DUE TO METALLOSIS FROM AN EXISTING FEMORAL SIDE PLATE. B. PLEASE CONFIRM IF THERE WAS FRACTURE OF THE DISTAL FEMUR. -NO, THERE WAS NO FRACTURE.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 17396278 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIA SLEEVES AT THE BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON PERFORMED ONE STAGE REVISION AS PATIENT ASPIRATION GREW OUT MRSA. ALL COMPONENTS REMOVED AND REPLACED. CEMENT WAS OWNED BY HOSPITAL SO NO INFORMATION WAS AVAILABLE IN OUR RECORDS. DOI: (B)(6), 2020 DOR: (B)(6), 2020 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10522698 ↗