ATTUNE 1518-20-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295541837), received between Mar 1, 2023 and Sep 28, 2026 — classified as 1 death, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain. No loosening nothing further to report.Affected Side: Left Knee.

  Patient problems: Pain

  MAUDE report 50913641 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN OCCURRED. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Pain

  MAUDE report 25330613 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SPILT OPENED WOUND, CHANGED THE POLY IN CASE OF PRESENT INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 24800171 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24413886 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST TKA, OPENING PATIENT INCISION AND CAPSULAR REPAIR. IT WAS ALSO NOTED THAT THE PATIENT HAD RUPTURED SOME OF THE LATERAL STRUCTURES RESULTING IN SOME INCREASED LATERAL SPACE IN FLEXION. AN I&D TO INCLUDE POLY EXCHANGE, PLACEMENT OF INSERT AND RESORBABLE ANTIBIOTIC BEADS WAS PERFORMED WITH NO DELAY NOR PATIENT HARM. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, SIMPLY AN EXCHANGE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 21139392 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS DEEMED TO BE UNSTABLE IN FLEXION. SURGEON UPSIZED POLY INSERT AND WAS HAPPY WITH STABILITY. THERE WAS NO COMPLAINT OR DELAY IN PROCEDURE. THE INSTABILITY WAS NOT RELATED TO POLYETHYLENE WEAR. THERE WAS NO REPORTED MALPOSITION OF COMPONENTS THAT LED TO INSTABILITY. NO COMPONENTS WERE UNDERSIZED ON THE PRIMARY SURGERY. THE FEMUR AND TIBIA WERE NOT EXCESSIVELY RESECTED DURING THE PRIMARY SURGERY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21047850 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT KNEE REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO INFECTION. A WASHOUT AND POLY EXCHANGE WERE PERFORMED. ORIGINAL SURGERY AND IMPLANT WERE PERFORMED ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20271189 ↗
• DeathFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). ASSOCIATED STUDY: REGISTRY DATE OF EVALUATION: (B)(6) 2024 DATE OF ONSET: (B)(6) 2024 DIAGNOSIS: DEATH ADVERSE EVENT: SPECIFY: COUNTRY: US SERIOUS: YES DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: REMOTE POSSIBILITY SUBJECT'S AGE AT ENROLLMENT: 78 SUBJECT'S GENDER: MALE SUBJECT'S HEIGHT: 70 IN SUBJECT'S WEIGHT: 142 LBS (B)(6) ARE RELATED TO EACH OTHER. BOTH COMPLAINTS ARE CREATED FOR THE BILATERAL KNEES. (B)(6) CAPTURE THE LEFT KNEE. (B)(6) CAPTURE THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18747698 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAPPED DURING I&D. SURGICAL DELAY UNKNOWN. DOI: ON (B)(6) 2023 DOR: ON (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18140107 ↗
• MalfunctionMar 1, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE MEDIAL STABILIZED INSERT WOULD NOT LOCK INTO THE FIXED BEARING TRAY UPON IMPACTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458575 ↗