ATTUNE 1523-05-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295057604), received between Jul 19, 2021 and Jan 28, 2026 — classified as 5 injuries.

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.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 29 DEC 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: 29 DEC 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).

  Patient problems: Unspecified Infection

  MAUDE report 24200720 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968143 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM IN (B)(6) WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. DERS WERE SUBMITTED. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND POSSIBLE INFECTION (NOT CONFIRMED AT THAT TIME) AT (B)(6). CAPTURED IN (B)(4). AT THE SAME TIME, ON (B)(6) 2025, AN I&D AND INS

  Patient problems: Unspecified Infection

  MAUDE report 21884114 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PREVIOUSLY REVISED KNEE WAS REVISED A SECOND TIME DUE TO PAIN AND INSTABILITY. THE PATIENT'S ATTUNE REVISION KNEE COMPONENTS WERE REMOVED AND REPLACED BY AN S-ROM NOILES HINGED FEMUR, AN LPS HINGED RP INSERT, AND A SIGMA REVISION MBT TIBIAL TRAY. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WOULD HAVE BEEN USED IN THE PRIOR REVISION PROCEDURE, SINCE THE HOSPITAL ONLY STOCKS SMARTSET CEMENT. THE PRODUCT CODES AND LOT NUMBERS FOR THE CEMENT IS NOT AVAILABLE, SINCE THE CEMENT USED WAS HOSPITAL INVENTORY ORDERED DIRECTLY FROM DEPUY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13170681 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT "PAIN WITH LEVEL WALKING = 8".

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12189570 ↗