ATTUNE LPS 1517-60-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295491088), received between Feb 25, 2021 and Jun 17, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 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 INSTABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22226206 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Extraskeletal ossification; Unspecified Infection

  MAUDE report 22159252 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT CONTINUES TO DRAIN AFTER BILATERAL REVISION TKAS FOR INFECTION. CULTURES FROM PREVIOUS CASES ALL SHOW THE SAME SENSITIVE ORGANISM BUT DRAINAGE CONTINUES TO OCCUR EVEN WITH COMPLETE IMPLANT EXCHANGE . A THOROUGH I&D WITH POLY EXCHANGES WERE PERFORMED ON BOTH SIDES WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WITHOUT SURGICAL DELAY OR PATIENT HARM. CULTURES WERE TAKEN ON BOTH SIDES INTRAOPERATIVELY. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE RIGHT KNEE. THE LEFT KNEE IS CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 21995817 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION FROM A PREVIOUS DISTAL FEMUR REPLACEMENT. THE DOCTOR WASHED OUT THE KNEE AND REPLACED THE POLY AND HINGE PIN. THIS WAS THE SECOND POLY SWAP FOR THIS KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17957617 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE WASHOUT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17564149 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A LPS REVISION KNEE FROM A FEW MONTHS AGO. THEY HAD TO DO A WASHOUT AND LINER EXCHANGE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15439501 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S PATELLA WAS TRACKING IMPROPERLY. SURGEON ALSO DECIDED TO REPLACE POLY (FROM 16MM TO 18MM) TO IMPROVE STABILITY. DOI: (B)(6) 2021; DOR: (B)(6) 2021 ; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13093667 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REIVSED TO ADDRESS INSTABILITY. SURGEON HAD CHOSEN TO DELIBERATELY KEEP THE LIMB A LITTLE SHORT AS THE PT WAS POST STATIC SPACER. SURGEON BROUGHT PATIENT BACK AND ADDED LENGTH IN BOTH SEGMENT AND THICKER INSERT. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11378282 ↗