ATTUNE 1523-07-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295057642), received between Jan 25, 2018 and Aug 27, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Sep 9, 2021Class IITerminated

   Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

   Z-0074-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT FULL ATTUNE KNEE REVISION DONE IN (B)(6) 2023. PATIENT STARTED TO EXPERIENCE TIBIA PAIN ABOUT 3 MONTHS AGO. SURGEON DID A BONE SCAN AND FOUND THE TIBIA WAS ¿HOT¿. SURGEON FELT THE TIBIA STEM WAS CAUSING THE TIBIA COMPONENT TO BECOME LOOSE. REMOVED ONLY THE TIBIA AND DID A TIBIA ONLY REVISION. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22905273 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SEPSIS. DEVICE RELATEDNESS: NO INFORMATION PROVIDED. PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: UNK (B)(6) 2024, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333280 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SEPSIS: DATE OF EVENT: UNK DEC 2024. DATE OF IMPLANT: (B)(6) 2019. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333269 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18950471 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18934435 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID; (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 14598023 ↗
• MalfunctionJun 29, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT INCORRECT SCREWS FOR THE 5MM TIBIAL AUGMENT WERE PLACED IN THE PACKAGING OF 2 SIZE 7/8 5MM IMPLANTS. BOTH OF THESE AUGMENT PACKAGES SHARED THE SAME LOT NUMBER (J6304Z). THE SCREWS IN THE SET WERE FOR A 10MM AUGMENT. THEY WERE CLEARLY TOO LONG. IN ORDER TO RESOLVE THE ISSUE, SCREWS INSIDE OF THE SIZE 5/6 5MM TIBIAL AUGMENTS WERE OPENED. BOTH 7/8 PACKAGES HAD THE WRONG SCREWS IN THEM. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12087801 ↗
• MalfunctionJun 29, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT INCORRECT SCREWS FOR THE 5MM TIBIAL AUGMENT WERE PLACED IN THE PACKAGING OF 2 SIZE 7/8 5MM IMPLANTS. BOTH OF THESE AUGMENT PACKAGES SHARED THE SAME LOT NUMBER (J6304Z). THE SCREWS IN THE SET WERE FOR A 10MM AUGMENT. THEY WERE CLEARLY TOO LONG. IN ORDER TO RESOLVE THE ISSUE, SCREWS INSIDE OF THE SIZE 5/6 5MM TIBIAL AUGMENTS WERE OPENED. BOTH 7/8 PACKAGES HAD THE WRONG SCREWS IN THEM. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12087797 ↗
• InjuryJan 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7218130 ↗