ATTUNE 1518-20-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295541882), received between Sep 15, 2023 and Aug 13, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient complained of patella femoral pain. Surgeon revised patella, and implanted the same size insert.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected Side: Left Knee.

  Patient problems: Pain

  MAUDE report 50241109 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LAXITY. DOI-(B)(6) 2025. DOR-(B)(6) 2026. AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25858107 ↗
• MalfunctionMar 20, 2026Difficult to Insert

  IT WAS REPORTED THAT THE DOCTOR HAS STARTED PUTTING THE POLY IN BEFORE THE FEMORAL COMPONENT. THEY SAID THAT THE FEMORAL CONDYLES WERE IN THE WAY AND WOULDN¿T ALLOW THE POLY TO SNAP INTO PLACE CORRECTLY. THEY TRIED IT TWICE AND THEN REQUESTED A NEW POLY. THE SURGEON MADE NO INDICATION THAT THE ORIGINAL POLY WAS DEFECTIVE. DOE: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649715 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION DUE TO INFECTED TKA. THERE WAS IRRIGATION AND DEBRIDEMENT WITH LINER EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23881672 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY. SURGEON REPLACED POLY WITH THICKER ONE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23804825 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. I&D. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23687636 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT TKA WAS REVISED FOR INSTABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23383731 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED. THE DOCTOR WASHED OUT THE KNEE AND EXCHANGED THE INSERT FOR ANOTHER OF THE SAME SIZE. NO DELAY OR PATIENT INJURY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22939326 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED INFECTION IS REASON FOR REVISION. THE POLY INSERT WAS EXPLANTED. NO HARM WAS DONE TO THE PATIENT, NO DELAYS IN THE CASE. ALL EXPLANTED MATERIAL WAS REMOVED FROM THE FIELD. ORIGINAL IMPLANTATION DATE (B)(6) 2025. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22336001 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTION. WASH OUT WAS CONDUCTED. SZ 8, 5MM MS INSERT WAS EXTRACTED. A NEW INSERT WAS IMPLANTED AFTER WASHOUT. THERE WAS NO DELAY IN SURGERY AND NO INJURY TO PATIENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21943976 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21878222 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED A POLY TO DO SOFT TISSUE RELEASES THEN REPLACED WITH SAME SIZE POLY INSERT. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 20750669 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THERE WAS NO SURGICAL DELAY TO REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 18988221 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH POLY EXCHANGE PERFORMED. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17757246 ↗