ATTUNE 1513-02-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295475125), received between Jun 3, 2021 and Jul 17, 2026 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 25853053 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE FEMORAL COMPONENT, ATTUNE FEMORAL STEM, AND ATTUNE TIBIAL INSERT WERE REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 22716855 ↗
• InjuryApr 22, 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 LOOSENING OF COMPONENTS OF LEFT KNEE DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89, COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151302000, LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET ADA

  Patient problems: Insufficient Information

  MAUDE report 21882279 ↗
• InjuryOct 25, 2024Adverse 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 EVENTS RECEIVED FOR INSTABILITY. DATE OF EVENT: 24 OCT 2019, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION AND CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Laxity

  MAUDE report 20536115 ↗
• 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: ON (B)(6) 2017, DATE OF EVENT: UNK JAN 2018, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, ORAL MEDICATION, AND PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 16451984 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE) TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY

  Patient problems: Pain

  MAUDE report 11934154 ↗