ATTUNE 1506-40-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295042761), received between Apr 20, 2023 and Jul 17, 2026 — 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.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THESE PRODUCTS IMPLANTED ON (B)(6) 2026. LATER THAT NIGHT IN THE PACU SHE SUSTAINED A KNEE DISLOCATION, REASONS UNKNOWN. THERE WAS NO EVENT THAT TRIGGERED IT. ACCORDING TO THE DR. ¿IT JUST SORT OF HAPPENED WITHOUT AN INCIDENT. THE DR STATS THAT THE PATIENT HAS A HISTORY OF COMPROMISED SOFT TISSUES OF THE LEFT KNEE. SO, THE DR EXPLANTED ALL COMPONENTS AND IMPLANTED A HINGE KNEE REVISION PROSTHESIS. DOI: ON (B)(6) 2026, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25852928 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC RIGHT MEDIAL POSTERIOR KNEE PAIN. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 7 JAN 2025. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION, PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 23404936 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN. SURGEON REVISED STEM TO A SHORTER STEM. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16777306 ↗

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