ATTUNE 1520-20-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295542483), received between Dec 11, 2023 and Sep 23, 2026 — classified as 14 injuries, 2 malfunctions.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implant removed due to infection. No patient consequence. No surgical delay.Affected side: Right Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50867609 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 1. (B)(6) 2024. 2. PT FELT LOOSE IN BOTH FLEXION AND EXTENSION. 3. NO PATIENT CONSEQUENCE.

  Patient problems: Joint Laxity

  MAUDE report 24496549 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT; ON (B)(6) 2026, THE ENTIRE IMPLANT WAS REMOVED BECAUSE NO IMPROVEMENT IN THE POSTOPERATIVE INFECTION WAS OBSERVED FOLLOWING THE INSERT EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 24190185 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A POLY EXCHANGE AND WASHOUT FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24130211 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP WAS DONE FOR RETINACULUM TEAR. THERE WAS NO ISSUES WITH IMPLANTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23924453 ↗
• InjuryDec 3, 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 DOI: (B)(6) 2023. DOR: (B)(6). 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23706798 ↗
• InjurySep 4, 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 POOR MOTION. THERE WAS LOOSENING OF THE TIBIA. THE LOOSENING OF THE INTERFACE WAS CEMENTED TO THE IMPLANT. THE CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22970389 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SURGERY AND AT SOME POINT, BECAME INFECTED, CAME BACK FOR POLY EXCHANGE/I AND. THE POLY WAS REPLACED WITH A 5X6 FBMS RIGHT, ONE SIZE THICKER. THERE WERE NO PROBLEMS WITH IMPLANTS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22017526 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DETERMINED THE KNEE TO BE UNSTABLE AND DECIDED TO INCREASE POLY THICKNESS. THERE WAS NO DELAY OR COMPLAINTS AND EXPLANTED INSERT IS NOT AVAILABLE FOR RETURN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21739834 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21206865 ↗
• MalfunctionJan 1, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON COULD NOT GET THE POLY INSERT TO FULLY SEAT. AFTER MULTIPLE SEATING ATTEMPTS, SURGEON RESORTED TO OPENING ANOTHER POLY THAT SAT FLUSH AFTER THE INITIAL IMPACTION. DOE: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21051841 ↗
• MalfunctionAug 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE POLY INSERT WAS BEING IMPLANTED IT BROKE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 19971279 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT UNSTABLE. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18467567 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. THERE WAS SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18464017 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT-SIDE TOTAL KNEE I&D POLY EXCHANGE. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18310469 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE POLY EXCHANGE I&D. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 18306226 ↗