ATTUNE 1506-11-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295416241), received between Oct 29, 2021 and Apr 1, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE WITH TRUMATCH. OVERSIZE TIBIA 2 WITH POSTERIOR PAIN. IT WAS CHANGED TO TIBIA 1.

  Patient problems: Pain

  MAUDE report 21742712 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16709079 ↗
• InjuryDec 20, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION OF A LOOSE AND SUBSIDED ATTUNE RP TIBIAL BASEPLATE (POROCOAT) TO A REVISION RP TIBIAL TRAY WITH SLEEVE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16013294 ↗
• InjuryOct 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA AND DIAGNOSTIC INTERVENTION (SCINTIGRAPHY AND X-RAYS).

  Patient problems: Pain

  MAUDE report 15612692 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTIONS (SCINTIGRAPHY AND X-RAYS) AND MANIPULATION UNDER ANESTHESIA.

  Patient problems: Pain

  MAUDE report 15502115 ↗
• InjuryApr 27, 2022Migration; Migration

  IT WAS REPORTED THAT AN UPCOMING REVISION OF A CEMENTLESS ATTUNE KNEE (LIKELY TO BE TIBIAL REVISION ONLY DUE TO PAIN AND SUSPECTED LOOSENING). THE ORIGINAL SURGERY WAS DONE APPROXIMATELY 3 MONTHS AGO. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Adhesion(s); Inflammation; Pain

  MAUDE report 14218819 ↗
• InjuryOct 29, 2021Migration; Migration

  REVISION OF SUBSIDED ATTUNE CEMENTLESS TIBIAL BASE PLATE. TIBIA ONLY REVISION DONE FOR THIS CASE DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT SIDE.

  Patient problems: Pain

  MAUDE report 12719184 ↗