ATTUNE 1518-20-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295541653), received between Jan 9, 2024 and Aug 12, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50225039 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP PERFORMED DUE TO SUSPECTED INFECTION. NO ACCESS TO CONFIRM INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25013278 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. A POLY SWAP WAS PERFORMED. NOTHING FURTHER TO REPORT. NO SURGICAL DELAY, NO LOOSENING. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24508269 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY INSERT WAS REMOVED AND REPLACED DUE TO INSTABILITY IN THE PATIENT. THERE WAS NO DELAY OR HARM TO THE PATIENT & HAVE NO FURTHER INFORMATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025 . AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21972885 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRODUCT WAS REVISED FOR LOSS OF RANGE OF MOTION. SURGEONS HAD TO REMOVE SCAR TISSUE AND THEN PUT SAME SIZE INSERT BACK IN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED AREA: LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 21918509 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED A SECOND TIME FOR POSSIBLE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21873216 ↗
• InjuryJan 24, 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 AND UNDERWENT POLY SWAP. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21234076 ↗
• MalfunctionJan 9, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2024. THE LOCKING TAB OF A KNEE INSERT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21118355 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Unspecified Infection

  MAUDE report 20558935 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2024 DUE TO A POLY EXCHANGED AND IRRIGATION AND DEBRIDEMENT (I&D). ORIGINAL SURGERY WAS ON LEFT KNEE ON (B)(6) 2024. IT IS UNKNOWN WHY THE POLY WAS EXCHANGED. THERE WAS NO HARM TO THE PATIENT, SURGICAL DELAY, OR BROKEN INSTRUMENTS.

  Patient problems: Insufficient Information

  MAUDE report 20260769 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A WASH OUT FOR POLY SWAP. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20012646 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE OLD POLY WAS REMOVED AND INSERTED A NEW ONE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19594643 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY WERE DOING AN EXPLANT OF COMPONENTS AND PUTTING IN AN ANTIBIOTIC SPACER. DOI: (B)(6), 2023. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18611084 ↗
• InjuryJan 9, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE RIGHT KNEE WAS BEING OPERATED ON AND A LEFT MS POLYS WAS PUT IN AFTER PATIENT WAS TAKEN TO PACU. THEN REALIZED IT WAS A LEFT POLY AND MADE STAFF AND SURGEON AWARE OF THE ERROR. PATIENT HAD TO BE BROUGHT BACK TO TAKE IT OUT AND PUT CORRECT SIDE POLY IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE. ADDITIONAL EVENT INFORMATION: THE PATIENT WAS BROUGHT BACK AT THE END OF THE DAY WHICH LENGTHEN THE DAY.

  Patient problems: Insufficient Information

  MAUDE report 18477591 ↗