ATTUNE 1506-80-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295492221), received between Nov 18, 2020 and Jun 17, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22231491 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE AN INFECTION. SO, SURGEON PULLED ORIGINAL IMPLANTS AND PUT IN A CEMENT SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21936258 ↗
• InjuryOct 5, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: -I DONT BELIEVE THE TIBIAL COMPONENT WAS LOOSE BUT IT WAS A LARGER MALE AND A DIFFICULT TO GET TO A POSITION TO EVEN HIT THE TRAY TO REMOVE. IF IT WAS LOOSE IT WAS FROM CEMENT TO BONE SINCE THE TRAY STILL HAD CEMENT OF IT. THEY USE GMV DEPUY CEMENT AND WOULD NOT KNOW THE LOT # SINCE THE BUY THE CEMENT DIRECTLY. THEY MIX IN PRISM 2 CARTRIDGE UNDER PRESSURE AND APPLY WITH A CEMENT GUN. THEY APPLY CEMENT TO THE TRAY FIRST ON THE BACK TABLE AND ALSO AFTER CLEANING BONE APPLY MORE CEMENT TO THE BONE SURFACE. THEY USUALLY MIX CEMENT FOR AROUND A MINUTE AND HALF AND START APPLYING AS SOON AS ITS READY.

  Patient problems: Discomfort

  MAUDE report 17878227 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17395648 ↗
• InjuryNov 18, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PRIMARY IMPLANTS WERE OVERSIZED CAUSING PAIN AND SUSPECTED POTENTIAL OSTEOMYELITIS. SURGEON DECIDED TO TAKE ALL IMPLANTS OUT AND REPLACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10860603 ↗