ATTUNE 1517-00-714Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295055068), received between Jul 12, 2023 and Jan 3, 2024 — classified as 3 injuries.

5 other recalls cover devices cleared under the same FDA submission (K160700, K241000); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POLY EXCHANGE DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18435805 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Swelling/ Edema

  MAUDE report 17488309 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO EITHER DEVICE OR PROCEDURE. DATE OF IMPLANT: (B)(6) 2023; DATE OF EVENT: (B)(6) 2023; (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17309089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160700, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0632-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
• Z-0631-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
• Z-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee