ATTUNE 1504-11-126Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295041993), received between Oct 3, 2019 and Sep 9, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF STIFFNESS AND PAIN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23011701 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ATTUNE LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 22024771 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY. BONE WAS FRACTURED PRE OP WHICH WAS REASON FOR REVISION.

  Patient problems: Limb Fracture

  MAUDE report 18977076 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18886705 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATTUNE RPPS CONSTRUCT ON (B)(6) 2023. SHE RECEIVED A PRESSFIT PS FEMUR, CEMENTED RP TIBIA, RPPS INSERT, 35 ANATOMIC PATELLA. UNFORTUNATELY, SHE EXPERIENCED A FALL 2 WEEKS AGO. IT WAS NOTED THAT SHE DEHISCED HER SURGICAL CLOSURE. IT IS SUSPECTED THIS IS HOW SHE BECAME INFECTED. UPON OPENING OF THE KNEE FOR THE WASHOUT ON MONDAY (B)(6) 2023, SHE DRAINED PUS AND WAS CONFIRMED FOR INFECTION. ALL PARTS AND PIECES WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED TO TREAT THE CONFIRMED INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 17397544 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND POOR MOTION. DOI: (B)(6) 2019, DOR: (B)(6) 2023, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16573040 ↗
• InjuryJun 15, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT FELL AND COLLAPSE THE FEMORAL COMPONENT FURTHER INTO THE DISTAL MEDIAL FEMUR CAUSING THE CEMENTLESS FEMORAL COMPONENT TO LOOSEN. NO HARM TO PATIENT. REVISED TO CRS CEMENTED WITH CEMENT STEM. AND A POLY SWAP. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 14697324 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY OF THE LEFT KNEE. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14631563 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL VEIN THROMBOSIS BOTH SIDES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD, EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Code Available; Thromboembolism

  MAUDE report 9150506 ↗