ATTUNE 1520-20-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295542667), received between Dec 8, 2022 and Apr 22, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE AND RESURFACED THE PATELLA DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24955129 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. SURGEON PERFORMED I&D WITH POLY EXCHANGE. THERE WERE NO COMPLAINTS OR DELAYS AND NO HARM TO PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 24936519 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24307944 ↗
• InjuryJan 7, 2026Use of Device Problem

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON REMOVED THE PATIENT'S PRIMARY PRESS-FIT TIBIAL TRAY AND INSERT. HE THEN RECUT THE PATIENT'S PROXIMAL TIBIA, VARYING SLIGHTLY THE INITIAL VARUS VALGUS ANGLE AND POSTERIOR SLOPE. HE THEN IMPLANTED A REPLACEMENT REVISION TIBIAL TRAY, WITH A SHORT CEMENTED STEM AND AUGMENTS ATTACHED, AND A THICKER REPLACEMENT INSERT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23993139 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S INSERT WAS REVISED DUE TO INSTABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23958304 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT SCAR AND CAPSULE DEBRIDEMENT, POLY SWAP AND PATELLA RESURFACING FOR STIFF KNEE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 22008472 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21298505 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT FELL AFTER HAVING THEIR KNEE REPLACED ON THE SAME DAY. THEY OPENED THEIR INCISION WHEN THEY FELL. THE DOCTOR WASHED OUT THE KNEE AND SWAPPED OUT THE INSERT WITH THE SAME SIZE. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 19097121 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TOO TIGHT IN FLEXION. SO SURGEON REMOVED THE 7 MM POLY AND REPLACED WITH A 5 MM POLY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18426719 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18191085 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE AFTER APPROXIMATELY 3-4 WEEKS. SURGEON REMOVED PRESSFIT FEMUR AND TIBIA AND AOX INSERT. THE SURGEON PERFORMED AND IRRIGATION AND DEBRIDEMENT AND CEMENTED IN A PS FEMUR AND ALL POLY STABILIZED INSERT. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15942432 ↗