ATTUNE 1517-00-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295054924), received between Sep 16, 2019 and Jan 23, 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.

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

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR NO INFORMATION PROVIDED. DCLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE OEDEMA. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: DEFINITELY. TREATMENT/IMPACT: OTHER (DRAINAGE). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440106 LOT NUMBER: J0841J COMPONENT TYPE: FEMORAL COMPONENT DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED CATALOG NUMBER: 150640004 LOT NUMBER: 9640684 COMPONENT TYPE: TIBIAL BASE COMPONENT DESCRIPTION: ATTUNE REVISION TIBIAL BASE FIXED BEARING SIZE 4 CEMENTED. CATALOG NUMBER: 151700608 LOT NUMBER: H80128 COMPONENT TYPE: TIBIAL INSERT COMPONENT DESCRIPTION: ATTUNE REVISION CRS FIXED BEARING INSERT SIZE 6 8 MM. CATALOG NUMBER: 66017750 LOT NUMBER: 95654956 COMPONENT TYPE: CEMENT DESCRIPTION: HERAEUS MEDICAL GMBH PALACOS CEMENT. CATALOG NUMBER: 66017750 LOT NUMBER: 95904875 COMPONENT TYPE: CEMENT DESCRIPTION: HERAEUS MEDICAL GMBH PALACOS CEMENT.

  Patient problems: Swelling/ Edema

  MAUDE report 24159668 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR THROMBOSIS (LEFT TIBIAL VEIN) 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) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11207497 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available; Pulmonary Embolism

  MAUDE report 9071863 ↗

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-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