ATTUNE 1517-10-614Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295056058), received between Jan 29, 2020 and May 6, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI- UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25104573 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 25104548 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24159969 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY IN THE JOINT. SURGEON REMOVED & REPLACED POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23924417 ↗
• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A DISLOCATED KNEE. SURGEON TOOK OUT THE 6X14 CRS INSERT AND IMPLANTED A 4X16 CRS POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 22663220 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE DONE FOR INFECTION. NO HARM TO PATIENT; NO DELAYS; NO BROKEN INSTRUMENT. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 21902000 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS REVISED DUE TO INFECTION. AN ARTICULATING SPACER AND ANTIBIOTICS WERE PLACED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21764067 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT I/D POLY SWAP. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21632799 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN RESULTING FROM POSSIBLE INFECTION OR INSTABILITY. CULTURES WERE TAKEN, KNEE WAS WASHED OUT, AND POLY INSERT WAS UPSIZED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 20416989 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY SWAP COMPLETE REVISION. COMPONENTS WERE WELL FIXED. THE SURGEON ELECTED TO CLEAN UP SCAR TISSUE AND DOWNSIZE THE POLY ONE SIZE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 19342103 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18949390 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND TORE THEIR ARTHROTOMY OPEN. WASHOUT POLY EXCHANGE PERFORMED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 18191773 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION FOR A POLY SWAP DUE TO A SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17549749 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY EXCHANGE AND IRRIGATION AND DEBRIDEMENT (I/D) FOR POSSIBLE INFECTION. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17404710 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH SUSPECTED INFECTION POST 2 STAGE REVISION KNEE. PATIENT HAD RECURRENT INFECTIONS AND MULTIPLE COMORBIDITIES TO INCLUDE DIALYSIS. A HEMATOMA WAS PRESENT WHICH WAS EVACUATED AND A THOROUGH I&D WAS PERFORMED, A POLY EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 17396966 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR INFECTION, PATIENT HAD BEEN REVISED FOR INFECTION IN THE PAST. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP-01491325: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491326: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491327: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491328: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491329: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491330: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491331: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491332: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491333: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491334: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01491335: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE,

  Patient problems: Unspecified Infection

  MAUDE report 15190993 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HAVING KNEE ISSUES WITH BALANCE. UPON EVALUATION OF THE KNEE, THE MCL WAS QUITE LAX AND WAS UNABLE TO ADDRESS WITH CORRECTION. SURGEON ELECTED TO REVISE THE KNEE TO A SROM HINGE KNEE. THE CEMENT MANUFACTURER WAS NOT INDICATED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15147386 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS AN INFECTED RIGHT TOTAL KNEE. THE SURGEON DID WASHOUT AND TIBIAL INSERT EXCHANGE. NO LOOSE COMPONENTS AND NO DELAY TO SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11353607 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10401802 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9890743 ↗
• InjuryJan 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A POSTERIOR TIBIAL OSTEOTOMY AND POLY EXCHANGE ON MONDAY. ON TUESDAY, HE FELL AND DISLOCATED THE KNEE ANTERIORLY. ANOTHER POLY SWAP AND AN EXFIX WERE DONE TO ALLOW THE LEG TO HEAL IN EXTENSION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9641943 ↗