ATTUNE 1517-10-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295055983), received between Dec 6, 2019 and Nov 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 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.

• InjuryNov 19, 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 LATERAL "KNEE" PAIN ON LEFT KNEE FOUND TO HAVE TIBIAL AND FEMORAL COMPONENT LOOSENING DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: JAN 2025. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440105. LOT NUMBER: J48D18. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED LEFT SIZE 5. CATALOG NUMBER: 151320110. LOT NUMBER: J06T70. COMPONENT TYPE: FEMORAL STEM. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION PRESSFIT STEM 20X110MM. CATALOG NUMBER: 154705003. LOT NUMBER: J1075X. COMPONENT TYPE: FEMORAL MEDIAL DISTAL AUGMENT. DESCRIPTION: XXX. CATALOG NUMBER: 154705003. LOT NUMBER: J3653X. COMPONENT TYPE: FEMORAL LATERAL DISTAL AUGMENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION DISTAL FEMORAL AUGMENT 12MM CEMENTED SIZE 5. CATALOG NUMBER: 154905001. LOT NUMBER: J5003D. COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION POSTERIOR FEMORAL AUGMENT 4MM CE

  Patient problems: Pain

  MAUDE report 23593052 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE POLY WAS REPLACED WITH SAME SIZE. NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20320533 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: MEDICAL RECORDS: ON (B)(6) 2024, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TIBIAL COMPONENT, IRRIGATION AND DEBRIDEMENT, AND PLACEMENT OF STIMULAN PELLETS TO ADDRESS ACUTE HEMATOGENOUS SEPSIS, LEFT TOTAL KNEE ARTHROPLASTY. PATIENT WAS PREVIOUSLY REVISED 5 YEAR AGO TO ADDRESS A FUNGAL INFECTION AND HAD BEEN DOING WELL. (NO OTHER INFO PROVIDED ON THAT PREVIOUS REVISION) THE PATIENT FELL, SUSTAINED A LARGE WOUND IN THEIR LOWER LEGS , THEN DEVELOPED CELLULITIS AND THEN A SECONDARY SEPTIC KNEE. THE SURGEON REPORTED FINDING A GROSSLY INFECTED KNEE. THE PATIENT HAD A POLY EXCHANGE AND PLACEMENT OF STIMULANT PELLETS.

  Patient problems: Cellulitis; Fall; Unspecified Infection

  MAUDE report 18796417 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A POLY SWAP DUE TO INFECTION. THE SURGEON ALSO INCREASED THE SIZE OF THE POLY AFTER TRAILING FOR EVEN BETTER STABILITY, AND THOROUGHLY WASHED OUT THE KNEE BEFORE IMPLANTING THE NEW POLY. DOI: UNKNOWN. DOR: ON (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18776921 ↗
• InjuryDec 6, 2019Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED TKREV. POLY REPLACED WITH THICKER AVAILABLE OPTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9430215 ↗