ATTUNE 1549-09-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295383161), received between Jul 14, 2020 and Jan 19, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 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 18541811 ↗
• InjuryJun 19, 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, DEVICE IN

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17151932 ↗
• 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 (DR (B)(6), (B)(6) HOSPITAL). 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 12933448 ↗
• 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 10924717 ↗
• MalfunctionJul 14, 2020Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  PATIENT WAS UNDERGOING A REVISION OF A REVISION (NO DEPUY PRODUCT) ON (B)(6) 2020 ( (B)(6) HOSPITAL) ALL COMPONENTS WERE REMOVED (NON DEPUY) AND AN ATTUNE REVISION SYSTEM WAS BEING UTILISED. THE ATTUNE FEMORAL CONSTRUCT REQUIRED POSTERIOR AUGMENTS ON BOTH THE MEDIAL AND LATERAL POSTERIOR CONDYLES. WHEN ATTEMPTING TO CONNECT THE LATERAL 8MM (SIZE 9) POSTERIOR AUGMENT, THIS AUGMENT WOULD NOT SEAT / CONNECT CORRECTLY - IT WOULD INITIALLY SEAT BUT WHEN AN ATTEMPT WAS MADE TO TIGHTEN THIS AUGMENT DOWN USING THE TORQUE DRIVER, THE AUGMENT WOULD LIFT SHOWING A GAP OF APPROXIMATELY 1MM. A NUMBER OF ATTEMPTS WERE MADE TO SEAT THIS AUGMENT BY RELEASING THE SCREW, RE SEATING THE AUGMENT AND RE FASTENING THE SCREW. NONE WORKED. AS AN ALTERNATIVE SIZE 9 X 8MM POSTERIOR AUGMENT WAS AVAILABLE, THIS WAS OPENED AND WHEN ATTACHING TO THE FEMUR, SEATED CORRECTLY. I HAVE REQUESTED THE FAULTY AUGMENT BE DECONTAMINATED AND KEPT IN ORDER FOR THIS TO BE LOOKED AT.

  Patient problems: Not Applicable

  MAUDE report 10271909 ↗