ATTUNE 1517-00-312Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295054610), received between Feb 25, 2022 and Jun 23, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D/POLY SWAP WAS PERFORMED FOR POSSIBLE INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25596326 ↗
• InjuryOct 16, 2025Adverse 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 PERSISTENT PAIN IN LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021 DATE OF EVENT: 01 DEC 2021 (LEFT KNEE). TREATMENT: ORAL MEDICATION AND DIAGNOSTIC INTERVENTION TREATMENT/IMPACT: INJECTED MEDICATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED): DEVICE LOG FORM LOG LINE: 1 COMPONENT TYPE: FEMORAL COMPONENT CATALOG NUMBER: 150440103 LOT NUMBER ID: JC2497 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 2 COMPONENT TYPE: TIBIAL BASE COMPONENT CATALOG NUMBER: 150640003 LOT NUMBER ID: 9773729 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 3 COMPONENT TYPE: TIBIAL STEM CATALOG NUMBER: 151214030 LOT NUMBER ID: D21063066 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 4 COMPONENT TYPE: TIBIAL INSERT COMPONENT CATALOG NUMBER: 151700312 LOT NUMBER ID: J03P07 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 5 COMPONENT TYPE: CEMENT CATALOG NUMBER: 66017750 LOT NUMBER ID: 97671012 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 6 COMPONENT TYPE: CEMENT CATALOG NUMBER: 66017750 LOT NUMBER ID: 97714988 DE

  Patient problems: Pain

  MAUDE report 23310112 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS IN JOINT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2017, DATE OF EVENT: (B)(6) 2018 (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, ORAL MEDICATION, AND PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 16451947 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL ORTHOPAEDIC HARDWARE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2017; DATE OF REVISION: (B)(6) 2021; DATE OF EVENT: (B)(6) 2021; (LEFT KNEE). TREATMENT: REVISION (INSERT WAS REMOVED) AND PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 15391913 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION OF RIGHT TOTAL KNEE REPLACEMENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT AND FEMORAL COMPONENT AND PHYSICAL THERAPY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 13601735 ↗

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-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-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-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