ATTUNE 1504-40-209Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295042327), received between Jul 9, 2020 and Jan 19, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 16, 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.

• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS POSITIVE FOR NICKEL ALLERGY AND IS SYMPTOMATIC TO INCLUDE ITCHING, RASHES, AND PAIN. ALL COMPONENTS WERE REMOVED SUCCESSFULLY WITHOUT PATIENT HARM OR DELAY AND A METAL SENSITIVE KNEE REVISION WAS PERFORMED UTILIZING COMPONENTS FROM A DIFFERENT MANUFACTURER. HIS INITIAL KNEE REVISION WAS PERFORMED ON THE DATE LISTED, HOWEVER A TIBIAL SIDE REVISION WAS ALSO PERFORMED ON (B)(6) 2023 DUE TO PAIN. A DER WAS SUBMITTED AT THAT TIME. IT WAS LATER, WHEN HIS PAIN PERSISTED THAT THE METAL ALLERGY TEST WAS PERFORMED AND HIS ALLERGY WAS CONFIRMED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Rash

  MAUDE report 18544188 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRODUCTS WERE EXPLANTED DUE TO INFECTION TO THE RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17539956 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION FEMORAL COMPONENT, INCLUDING SLEEVE AND STEM FOR STIFFNESS. PATIENT UNDERWENT REVISION ATTUNE APPROX 3 YEARS AGO (EXACT DATE UNKNOWN). PRESENTED WITH STIFFNESS, FIXED FLEXION AT 25-30 DEGREES. FEMORAL COMPONENTS REMOVED AND SROM ROTATING PLATFORM HINGE FEMORAL COMPONENT WITH ATTUNE CROSS OVER BEARING INSERTED. SURGEON ABLE TO GET FULL EXTENSION ON THE TABLE. TIBIAL COMPONENTS NOT REVISED. TRYING TO SOURCE COMPONENT SIZES AND LOT NUMBERS FROM CUSTOMER SERVICES. IF OTHER, DESCRIBE: REVISION OF ATTUNE REVISION FEMORAL COMPONENT TO SROM HINGE., WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY: NO, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVIC

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17062610 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS LINKED TO (B)(4) WHICH REPORTED ON THE NON-DEPUY PRIMARY SURGERY. PATIENT UNDERWENT REVISION KNEE SURGERY ON (B)(6) 2020 WHERE AN ATTUNE REVISION SYSTEM WAS UTILISED ((B)(6)). DEPUY CEMENT NOT UTILISED. PATIENT INITIALLY DID WELL BUT OVER TIME HAS HAD PROGRESSIVE RESTRICTION TO RANGE OF MOTION. PATIENT HAS PRESENTED WITH A STIFF KNEE. APPROXIMATELY 25 DEGREES OF EXTENSION TO 80 DEGREES FLEXION A DECISION WAS MADE TO OPEN THE KNEE, REMOVE AS MUCH SCAR TISSUE AS POSSIBLE AND EXCHANGE THE 8MM POLY INSERT TO A 6MM POLY INSERT. ALL COMPONENTS WERE WELL FIXED THE RANGE OF MOTION WAS IMPROVED TO APPROXIMATELY 5 DEGREES TO 110 DEGREES. DOI: UNKNOWN (NON-DEPUY PRODUCTS), DOR (1ST): (B)(6) 2020, DOR (2ND): (B)(6) 2021.

  Patient problems: Muscular Rigidity

  MAUDE report 12933451 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA- POST OP IRON SUBSTITUTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

  Patient problems: Anemia

  MAUDE report 10924724 ↗
• MalfunctionJul 9, 2020Tear, Rip or Hole in Device Packaging; Difficult to Open or Close; Tear, Rip or Hole in Device Packaging; Difficult to Open or Close

  PATIENT PS WAS UNDERTAKING REVISION KNEE SURGERY ON (B)(6) 2020 ( (B)(6)) AT TIME OF OPENING THE COMPONENTS, IT WAS NOTED THAT THE ATTUNE REVISION FEMORAL COMPONENT (SIZE 9 RIGHT) PACKAGING WAS DISTORTED AND HAD THE APPEARANCE THAT THE CLEAR PACKAGING HAD MELTED (TO SOME EXTENT - SEE PICTURES. THE PACKAGING WAS CHECKED VISIBLY FOR ANY POSSIBLE PERFORATIONS AND APPEARED IN TACT AND AS THERE WAS NO OTHER ALTERNATIVES AVAILABLE IN THE HOSPITAL OR IN THE LOCAL AREA, THIS WAS OPENED. ON OPENING THE FIRST LAYER OF STERILE PACKAGING, THE STERILE SCRUB NURSE WAS UNABLE TO REMOVE THE SECOND LAYER IN THE USUAL MANNER (DUE TO THE DISTORTION N THE PACKAGING. AS THERE WAS NO OTHER ALTERNATIVE, THE INNER WHITE PEEL COVER WAS REMOVED AND THE FEMORAL COMPONENT WAS TAKEN STERILE FROM THIS "INNER PACKAGING".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250572 ↗