ATTUNE 1517-10-714Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295056164), received between Nov 5, 2019 and Jul 27, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 22 most recent of 22 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 50039930 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WITH POLY EXCHANGE WAS DONE DUE TO SUSPECTED INFECTION. NO ALLEGATION AGAINST OUR IMPLANT NO RECORDS FROM THE INITIAL SURGERY ON LOT NUMBER. NO WAY TO CONFIRM PRESENCE OF INFECTIONS OR NOT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24305050 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR/WASHOUT AND LINER EXCHANGE OF AN INFECTED ATTUNE REVISION CONSTRUCT. THE SITE WAS THOROUGHLY CLEANED AND DEBRIDED, AND A NEW POLY WAS IMPLANTED. PATIENT HAS ALSO HAD A REVISION FOR A LOOSE PATELLA COMPONENT. THE PATELLA HAD DEBONDED FROM THE BONE. PRIOR HISTORY FOR THIS PATIENT WAS A UNI KNEE WHICH WAS REVISED FOR LOOSENING. THIS WAS CONVERTED TO AN ATTUNE +/- 8 YEARS AGO. THE TIBIA BECAME LOOSE (WHICH WOULD HAVE BEEN A FIRST GENERATION ATTUNE TIBIA); FEMORAL COMPONENT WAS WELL FIXED BUT HAD TO BE REMOVED IN ORDER TO GET THE TIBIAL COMPONENT OUT. IT WAS THEN REVISED TO THE ATTUNE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 23359822 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22531080 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY INSERT WAS EXPLANTED, AND A LARGER POLY WAS IMPLANTED DUE TO MILD INSTABILITY. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22030966 ↗
• InjuryMay 9, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR SPIN OUT. SURGEON EXPLANTED THE 14MM CRS RP REVISION INSERT AND IMPLANTED A 20MM CRS RP REVISION INSERT. THERE WAS NO DELAY OR CONSEQUENCES TO THE PATIENT. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21996247 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 21162871 ↗
• InjuryNov 5, 2024Adverse 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 OF HARDWARE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20609959 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: DOTS IT WAS REPORTED FROM CLINICAL STUDY AN ADVERSE EVENT RECEIVED FOR KNEE REVISION ON (B)(6) 2024 DUE TO JOINT INSTABILITY. DATE OF IMPLANT WAS (B)(6) 2022.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20428232 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19990325 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PAINFUL KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19553610 ↗
• InjuryApr 8, 2024Adverse 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 PAIN. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19058679 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. INSERT WAS EXCHANGED AND KNEE WASHED OUT. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18893705 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS TOTAL KNEE REVISION ON (B)(6) 2024. PATIENT WAS BROUGHT FOR SUSPECTED INFECTION. RIGHT KNEE WAS IRRIGATED AND A POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18866065 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. PATIENT HAD A REVISION KNEE ON (B)(6) 2024. SCHEDULED FOR AN I&D WITH POLY EXCHANGE FOR POSSIBLE INFECTION. ALL COMPONENTS ARE WELL FIXED. REMOVED THE INSERT TO DO A JOINT WASHOUT. WENT BACK WITH SAME SIZE INSERT. NO OTHER INFORMATION. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18768974 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15798302 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON REMOVED 14MM INSERT, WASHED OUT KNEE, AND IMPLANTED NEW INSERT OF SAME SIZE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13769288 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HEMATOMA. I&D AND POLY EXCHANGE WAS PERFORMED. PRESUMED CAUSE IS A ¿STUMBLE¿ DURING PHYSICAL THERAPY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Fall; Hematoma

  MAUDE report 12672613 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND POLY SWAP PROCEDURE WERE DONE. DOI: (B)(6) 2021; DOR: (B)(6)2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12289801 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE (B)(6) 2021 THE PATIENT HAD A ATTUNE REVISION REMOVED DUE TO INFECTION. I HAVEN'T BEEN ABLE TO OBTAIN THE PRODUCT LOT NUMBERS THAT WERE IN THE PATIENT. I WILL NEED TO CONTACT THE SURGEON OF THESE AS THE NURSING STAFF AT THE HOSPITAL WERE UNSURE. THE SURGEON PUT AN PALACOS ANTIBIOTIC CEMENT SPACER INTO THE PATIENT. THE IMPLANTS REMOVED: FEMORAL COMPONENT WITH FULLY PORUS SLEEVE AND PRESSFIT STEM, TIBIAL COMPONENT WITH FULLY PORUS SLEEVE, PRESSFIT STEM AND TIBIAL CRS INSERT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11332904 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INFECTION AND NEEDED A POLY EXCHANGE. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9855855 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY HAD BEEN REPLACED DUE TO INFECTION AND HEMATOMA. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 9278590 ↗