ATTUNE 1516-30-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295047797), received between Dec 28, 2020 and Sep 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 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) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23021856 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION POLY EXCHANGE WAS PERFORMED TO GIVE THE PATIENT BETTER R.O.M. A 10 MM INSERT WAS IMPLANTED AND 12 MM WAS EXPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 13769443 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PUT BACK IN A 5 RIGHT CR CEMENTED FEMUR AND A 5X12 RPCR POLY. WHILE PUTTING THE POLY BACK IN, THE PCL WAS RUPTURED SO SURGEON WENT UP TO A 5X14 RPCR. WHILE DOING THIS, SURGEON RESURFACED THE NATIVE PATELLA AND PUT IN A 38 DOME. DOE: (B)(6) 2022.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 13443785 ↗
• InjuryDec 28, 2020Unintended Movement; Unintended Movement

  BEARING SPUN OUT AND KNEE DISLOCATED. REVISED TO REVISION PROSTHESIS.

  Patient problems: Joint Dislocation

  MAUDE report 11083826 ↗