ATTUNE 1517-10-526Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295056003), received between Jun 15, 2020 and Aug 14, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 19981484 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 2022 WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON THE (B)(6) 2022 FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILITY, THIS PC, ON THE 05.02.23.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037455 ↗
• InjuryMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF A DISTAL FEMORAL REPLACEMENT DUE TO PRIOR INFECTION AND SOFT TISSUES STRETCHING EXTENSIVELY RESULTING IN THE DISLOCATION OF THE HINGED COMPONENT WITH THE LARGEST AVAILABLE POLY. THE DISTAL FEMORAL COMPONENT WITH A POROUS STEM WAS LOOSE AND REMOVED EASILY. THE DISTAL FEMORAL COMPONENT WAS REVISED TO A CEMENTED STEM AND A THICK MBT TRAY WAS IMPLANTED WITH A 21MM POLY. DOI: UNKNOWN, DOR: (B)(6) 2023, UNKNOWN SIDE.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Infection

  MAUDE report 16933691 ↗
• InjuryFeb 21, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED A SECOND REVISION WAS COMPLETED DUE TO DISLOCATION. THE FEMORAL COMPONENT, SLEEVE, AND STEM WERE REMOVED AND SROM HINGE WAS IMPLANTED SECONDARY TO BONE FRACTURE. DOI: 09/1/2022, DOR: 12/21/2022, AND DOR: 02/05/2023.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 16407290 ↗
• InjuryJun 15, 2020Unintended Movement; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS ROTATION OF THE TIBIAL INSERT. THE SURGEON REMOVED THE ATTUNE FEMORAL COMPONENTS AND REVISED THE KNEE TO AN S-ROM HINGE KNEE. THE PATIENT HAD A PREVIOUS REVISION OF THE TIBIAL INSERT DUE TO SUBLUXATION AND THE INSERT ROTATING 90 DEGREES. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10154992 ↗