ATTUNE 1506-11-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295416319), received between Dec 13, 2018 and Apr 2, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL ATTUNE KNEE THAT IS INFECTED. THE KNEE WAS IMPLANTED ON (B)(6) 2022 AND HAD AN INSERT EXCHANGE WASHOUT ON (B)(6) 2022. THE KNEE IS STILL INFECTED, SO THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED TEMPORARY IMPLANTS. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE. THE FIRST REVISION SURGERY INVOLVING THE INSERT EXCHANGE AND WASHOUT WAS CAPTURED IN (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19021075 ↗
• MalfunctionDec 11, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THE SEAL WAS NOT BREACHED, YOU COULD JUST NOT SEPARATE THE OUTER AND INNER BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307187 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE. PATIENT HAD FALLEN AND PATIENT WAS HAVING PAIN IN KNEE. SURGEON EXPLANTED THE IMPLANTS AND REVISED TO ATTUNE REVISION IMPLANTS. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 17817278 ↗
• InjuryMay 1, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16843692 ↗
• InjuryApr 14, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT REQUIRED A TIBIAL REVISION DUE TO A ATTUNE CEMENTLESS TIBIAL TRAY BEING LOOSE. ORIGINAL PRIMARY SURGERY WAS DONE ON THE (B)(6) 2022. PATIENT WAS COMPLAINING OF DISCOMFORT AND TRAY SHOWED ON A SCAN THAT IT WAS A HOT SPOT, SHOWING IT WAS LOOSE. TRAY WAS REMOVED AND A ATTUNE REVISION FB TRAY WAS IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. UNKNOWN KNEE.

  Patient problems: Discomfort; Inadequate Osseointegration

  MAUDE report 16742382 ↗
• InjuryDec 14, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SURGEON WAS REVISING THE TIBIAL TRAYS DUE TO LOOSENING OF THE COMPONENTS. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15979005 ↗
• InjuryDec 1, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON WAS REVISING THE TIBIAL TRAYS DUE TO LOOSENING OF THE COMPONENTS (NON CEMENTED). SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2022 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15896955 ↗
• InjurySep 2, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA (NON CEMENTED). THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15347094 ↗
• InjuryAug 9, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. DOI- UNKNOWN, DOR- (B)(4) 2022, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15191457 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HAEMARTHROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: INJECTED MEDICATION-ADDUCTOR BLOCK TO RELIEVE PAIN; PHYSICAL THERAPY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9764905 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS LEFT KNEE, EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019, (LEFT KNEE).

  Patient problems: Fibrosis

  MAUDE report 8990905 ↗
• InjuryMar 18, 2019Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8429593 ↗
• InjuryDec 13, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. ORIGINAL ATTUNE CEMENTLESS CR RP IMPLANTS WERE IMPLANTED ON (B)(6) 2018 BY DIFFERENT SURGEON.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8159996 ↗