ATTUNE 1516-50-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 10603295052562), received between Aug 8, 2017 and May 12, 2026 — classified as 178 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 reports).

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 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEEDED BIGGER POLY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25148670 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24971234 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT TKA; THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION PROCEDURE WITH DEBRIDEMENT AND THE INSERT REPLACEMENT DUE TO INFECTION/CELLULITIS. SEVERE CONTRACTURE MADE IMPLANT REMOVAL DIFFICULT. AFTER IRRIGATION, AN IMPLANT OF THE SAME SIZE WAS REIMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Cellulitis; Septic loosening; Unspecified Infection

  MAUDE report 24965810 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNEE REVISION WITH LINER EXCHANGE DUE TO INSTABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24558433 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL CREATING SOFT TISSUE DAMAGE. NO ALLEGATIONS AGAINST IMPLANT. PREVIOUS SURGERY DONE AT AN OUTSIDE INSTITUTION. NO ACCESS TO LOT NUMBER OR SURGERY DATE. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24497672 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE PATIENT WAS EXPERIENCING MID FLEXION INSTABILITY. THE INSERT WAS EXCHANGED FOR A THICKER INSERT. NO INJURY OR DELAYS. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24431812 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT COMPLAINED OF PAINFUL TKA. BOTH IMPLANTS WERE WELL FIXED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24369428 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT TOTAL ATTUNE KNEE THAT WAS UNIVERSALLY LIGAMENTOUSLY LAX. THE SURGEON REMOVED THE TIBIAL INSERT AND IMPLANTED A THICKER INSERT. ALL OTHER COMPONENTS ARE WELL FIXED AND RETAINED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24272370 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LATERAL KNEE PAIN, AND NEEDED SOFT TISSUE CLEAN OUT. POLY WAS REMOVED TO GET BETTER ACCESS TO SOFT TISSUE. CLEAN OUT WAS PERFORMED AND NEW POLY WAS PLACED. NO PROBLEMS WITH PREVIOUS PRODUCTS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24176537 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO AN INFECTED KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24085736 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS TIBIA REVISION FOR REPORT OF PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23959455 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE IS INFECTION IN THE LEFT KNEE TOTAL PROTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 23908296 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWING SIGNS OF INFECTION, THEREFORE UNDERWENT AN I&D AND A POLY SWAP. DOI-(B)(6) 2025. DOR-(B)(6) 2025. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23829197 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE PS FEM RT SZ 6 NAR CEM, ATTUNE RP TIB BASE SZ 5 CEM, ATTUNE MEDIAL ANAT PAT 35MM, AND ATTUNE PS RP INSRT SZ6 5MM WERE INVOLVED IN A REVISION OF AN ATTUNE KNEE SYSTEM DUE TO PERSISTENT PAIN FOLLOWING THE INITIAL PROCEDURE. ALTHOUGH TESTS FOR INFECTION AND LOOSENING WERE NEGATIVE, ELEVATED BLOOD MARKERS LED CLINICIANS TO TREAT THE CASE AS AN INFECTION, RESULTING IN A TWO-STAGE REVISION WHERE ALL COMPONENTS WERE EXPLANTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23819116 ↗
• InjuryNov 4, 2025Naturally Worn; Naturally Worn

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL TRAY, POLY WEAR, AND PAIN. THE NON-ARTICULAR SURFACE OF THE CEMENTED TIBIAL TRAY SHOWS NO CEMENT REMAINING. CEMENT MFG IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 23468625 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ALL IMPLANTS WERE EXPLANTED AND SPACER WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23075673 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF STIFFNESS AND PAIN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23011713 ↗
• InjuryAug 26, 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 PREVIOUS INFECTION AND UNEXPLAINED PAIN. A POLY EXCHANGED WAS PERFORMED. A FULL REVISION WAS DONE AND FULL DEBRIDEMENT PERFORMED PRIOR TO IMPLANTATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22897437 ↗
• InjuryJul 17, 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 AND POLY SWAP. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22532169 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY NEEDED THICKER POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22437712 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A TKA SURGERY FOR OA ON KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN (B)(6) 2025, THE PATIENT HAD PAIN AND AN INFECTION WAS DISCOVERED. THE REMOVAL SURGERY IS SCHEDULED ON (B)(6).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22395026 ↗
• InjuryMay 15, 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. ATTUNE LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 22024865 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT KNEE. SURGEON EXPLANTED THE POLY TO RELEASE SOME POSTERIOR STRUCTURES AND A NEW POLY WAS IMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE

  Patient problems: Muscular Rigidity

  MAUDE report 22021889 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION WAS SUSPECTED. NO LOOSENING OF IMPLANTS. THE POLY INSERT WAS STRUCK WITH AN OSTEOTOME AND MALLET, DAMAGING THE IMPLANT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21971934 ↗
• InjuryApr 1, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT TOTAL KNEE THAT HAS A CLICKING SENSATION. THE SURGEON DID A DEBRIDEMENT AND FOUND SOME LIGAMENTS THAT WERE TIGHT AND SNAPPING. THE SURGEON DID SOME RELEASES, AND THE KNEE MOVES NICELY. THE TIBIAL INSERT WAS ALSO EXCHANGED. DURING REASSEMBLY OF THE INSTRUMENTS, IT WAS DISCOVERED THAT THE RETAINING SPRING ON TRIAL INSERT WAS DAMAGED. ALL PIECES WERE PRESENT. A DEPUY SYNTHES PRODUCT BROKE DURING SURGERY AND ALL PIECES WERE RETRIEVED. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Unspecified Tissue Injury

  MAUDE report 21744908 ↗