ATTUNE 1517-00-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295054887), received between Sep 23, 2020 and Feb 19, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HOSPITALIZATION, FOR CLOSING OF THE FORAMEN OVALE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: SURGICAL INTERVENTION NOT RELATED TO THE STUDY PROCEDURE (NO PRODUCTS REVISED).

  Patient problems: Insufficient Information

  MAUDE report 11347958 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BRAIN STROKE (ISCHEMIC). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: NONE.

  Patient problems: No Code Available; Stroke/CVA

  MAUDE report 10575100 ↗

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-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee