ATTUNE 1511-11-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295436584), received between Aug 24, 2020 and May 15, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN DOING WELL AND PRESENTED IN AN OUTSIDE FACILITY WITH SUSPECTED INFECTION WHILE ON VACATION. A WOUND VAC WAS PLACED AND PATIENT RETURNED TO HIS TREATING SURGEON FOR CARE. ALL COMPONENTS WERE WELL FUNCTIONING AND WELL FIXED SO NO ALLEGATION WAS MADE AGAINST THE COMPONENTS. THERE WAS NO DELAY NOR PATIENT HARM WAS NOTED. A STATIC APACER WAS FASHIONED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTIC CEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THIS PATIENT HAS HAD INTERVENTIONS ON THE FOLLOWING DATES WHERE IMPLANTS WERE EXCHANGED AND DERS WERE SUBMITTED. (B)(6)2025 588018. (B)(6) 2025 589340. CEMENT UTILIZED WAS DEPUY 2 WITH GENT AND HOSPITAL OWNED. HIS PATELLAR COMPONENT HAD BEEN PLACED ON (B)(6) 2022 AND RETAINED FROM HIS PRIMARY TKA. DOI: (B)(6) 2025. DOR: APR 29, 2026. AFFECTED SIDE: LEFT KNEE. (B)(4) AND (B)(4) WERE CREATED FOR THE FIRST AND SECOND REVISION". ALL IMPACTED PRODUCTS IN THESE TWO PC'S ARE PART OF THE SAME THIRD REVISION SURGERY FOR ONGOING INFECTION--IN THIS THIRD REVISION ALL PRODUCTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS IMPLANTED." THE KNEE (WITH ALL OF THE CURRENT IMPACTED PRODUCTS EXCEPT THE INSERT) WAS DIS

  Patient problems: Unspecified Infection

  MAUDE report 25190311 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. SURGEON PERFORMED EXPLANT AND PLACEMENT OF AB SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23372978 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO REMAIN INFECTED. SURGEON ELECTED TO REMOVE SOME COMPONENTS AND FUSE THE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22027303 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRAINAGE POST SURGERY AND ELEVATED LABS INDICATIVE OF INFECTION. COMPONENTS WERE REMOVED AND A SPACER WAS MADE UTILIZING LPS COMPONENTS. DOI: (B)(6) 2022 DOR: (B)(6), 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19828715 ↗
• 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: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT.

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

  MAUDE report 18541815 ↗
• InjuryDec 12, 2022Osseointegration Problem; Osseointegration Problem

  TIBIAL COMPONENTS OF PATIENT'S RIGHT REVTKR BECAME LOOSE. SURGEON PERFORMED THE FIRST REVISION ON (B)(6) 2022 BUT DIDN'T KNOW THE CAUSE OF THE LOOSENING. HE HAD TO REMOVE FEMORAL COMPONENT TO GAIN ACCESS TO THE TIBIA, AND THEN REVISED TIBIA.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15962222 ↗
• InjuryOct 21, 2022Osseointegration Problem; Osseointegration Problem

  REVISION OF DEPUY TKR COMPONENTS FOR IMPLANT LOOSENING. LEFT KNEE. LOT NUMBERS NOT SOURCED. IMPLANTS DISCARDED. DOI: (B)(6) 2009, DOR (12TH): (B)(6) 2021, DOR (13TH): (B)(6) 2022.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15650235 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14688977 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2021. THE REVISION DATE FOR THE LOOSENING AND INFECTION IS (B)(6) 2021. (THIS WAS DOCUMENTED IN THE EVENT DESCRIPTION AS (B)(6) 2021 BUT THIS WAS A CLERICAL ERROR). THE REVISION DATE FOR THIS PC IS (B)(6) 2021. ALL IMPLANTS WERE REVISED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14013037 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. INFECTION DEVELOPED FOLLOWING TKA. THE SURGEON STATED KNEE IS STILL INFECTED AND ELECTED TO REMOVE ALL IMPLANTS AND INSERT AN ANTIBIOTIC SPACER TO ADDRESS THE ISSUE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13536604 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN. ALL COMPONENTS WERE REMOVED AND REPLACED IN A SINGLE STAGE REVISION UTILIZING A DUAL SET UP. THE CEMENT WAS A DEPUY PRODUCT BUT THE INFORMATION WAS NOT AVAILABLE AS IT WAS A HOSPITAL OWNED INVENTORY AND NOT ON THE PAPERWORK. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 13168160 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE SEE PREVIOUS PC'S FOR THIS PATIENT AS THIS IS THE 3RD REVISION FOLLOWING THE PRIMARY. PATIENT HAS NOW PRESENTED WITH A SWOLLEN, HOT AND PAINFUL KNEE. ON OPENING THE KNEE THE WAS CLEAR EVIDENCE OF INFECTION WITH PUSS PRESENT. IF YES, PLEASE DESCRIBE THE INFECTION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13063144 ↗
• 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 12933446 ↗
• InjuryNov 9, 2021Migration; Migration

  1. PLEASE CONFIRM PRESENCE OF INFECTION? BACTERIA HAVE BEEN GROWN FROM THE SAMPLES TAKEN AT THE TIME OF REMOVING THE ATTUNE REVISION , INDICATING AN INFECTION. 2. WAS LOOSENING DUE TO INFECTION? YES. 3. IT WAS INDICATED IN THE EVENT DESCRIPTION THAT '' THE TIBIA APPEARS TO HAVE MOVED/ SUBSIDED ON THE MEDIAL SIDE WITH THE LONG 160MM CANAL FILLING STEM (LONG STEM WAS REQUIRED TO BYPASS THE ORIGINAL STEM) ABUTTING THE LATERAL CORTEX WHICH SHOWS SIGNS OF REMODELING. '' PLEASE CLARIFY, DID THE TIBIA SUBSIDE? YES IT DID. MOVING INTO VARUS WITH THE DISTAL TIP ABBUTTING THE DISTAL LATERAL CORTEX. 4. CAN YOU PLEASE ADVISE WHO THE MANUFACTURER OF THE PATELLA WAS. I WOULD GUESS IT WAS A ZIMMER BIOMET PATELLA.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12780592 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS A LONG HISTORY OF LT TKA WITH EXPLANT FOR INFECTION. INITIAL DOS (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; EXPLANT LEFT TKA WITH ANTIBIOTIC SPACER (B)(6) 2020; ATTUNE LEFT TKA REPLANT (B)(6) 2020; RE-INFECTED WITH EXPLANT AND SPACER (B)(6) 2021 WITH ALL HARDWARE REMOVED. THIS COMPLAINT IS FOR THE 6TH REVISION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12737190 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. COMPONENTS WERE EXPLANTED AND A STATIC ANTIBIOTIC SPACER WAS PLACED IN HOPE TO CLEAR INFECTION. NO LOOSENING REPORTED. NO DELAY TO SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11569521 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE BONE FRACTURE - RIGHT TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: SURGICAL OPEN REDUCTION INTERNAL FIXATION OF RIGHT TIBIA.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10442560 ↗