ATTUNE 1511-01-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295419594), received between Aug 13, 2020 and Feb 4, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATUNE PRESSFIT STR STEM14X60MM, ATUN TIB SLV M/L 45MM FULL POR, ATUNE REV RP TIB BASE SZ 4 CEM, ATTUNE REV LPS INSRT XXSM 12MM, LPS DISTAL FEM COMP XXSM RT, ATT REV SLV LPS FEM ADP +5, ATUN FEM SLV M/L 45MM FULL POR, AND ATUN PRESSFIT STR STEM12X110MM WERE INVOLVED IN A REPORTED EVENT. THE PATIENT, WHO HAD PREVIOUSLY RECEIVED A REVISION KNEE POST SPACER FOR INFECTION, PRESENTED WITH WOUND DRAINAGE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND THOROUGH DEBRIDEMENT AND IRRIGATION WERE PERFORMED. A NEW SPACER WAS FASHIONED USING LPS COMPONENTS, RESORBABLE ANTIBIOTIC BEADS, AND HIGH-DOSE ANTIBIOTIC CEMENT. NO DEVICE MALFUNCTION WAS ALLEGED, AND ALL COMPONENTS WERE REPORTED TO BE FUNCTIONING AS EXPECTED. THE TIBIAL COMPONENT WAS WELL FIXED, AND THE EVENT WAS ATTRIBUTED TO INFECTION RATHER THAN DEVICE FAILURE. ALL LISTED PRODUCTS WERE EXPLANTED DURING THE PROCEDURE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24258460 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STATIC SPACER PLACED DUE TO INFECTION. INFECTION CLEARED VIA ASPIRATION. PATIENT CONVERTED TO DISTAL FEMORAL REPLACEMENT UNEVENTFULLY. THERE WAS NO PATIENT HARM AND NO DELAY NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23730113 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE PLACED ON THE ABOVE LISTED DATE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22771838 ↗
• InjuryAug 23, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE AND THE IMPLANTS NEEDED TO BE REVISED TO LPS. THE LOOSENING INTERFACE WAS UNKNOWN AND CEMENT MANUFACTURER WAS UNKNOWN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17603675 ↗
• MalfunctionMay 15, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS LESS THAN 5 MINUTES OF SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931165 ↗
• InjurySep 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SURGERIES TOOK PLACE PRIOR TO THIS CASE UTILIZING JNJ IMPLANTS, (B)(6) 2020 WITH THE FIRST SURGEON AT THE HOSPITAL, AND THEN AT ANOTHER HOSPITAL WITH THE ANOTHER SURGEON ON (B)(6) 2021. THE INITIAL CASE WITH THE FIRST SURGEON WAS A TOTAL FEMUR FOR TREATMENT OF CHRONIC INFECTION. THE OTHER SURGEON THEN CONVERTED THE TOTAL FEMUR TO A KNEE FUSION AS HER QUAD MECHANISM FAILED. ULTIMATELY THE PATIENT HAD A HIP DISARTICULATION ON (B)(6) 2022 AS THE INFECTION RESURFACED. A DER WAS SUBMITTED WHEN THE SECOND SURGEON PERFORMED HIS PROCEDURE. NO PATIENT HARM WAS CREATED BY JNJ IMPLANTS. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15397934 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO THIGH PAIN. NO EVIDENCE OF INFECTION OR LOOSENING. SURGEON SUSPECTED THE PAIN MAY BE BEING GENERATED FROM A LARGE FEMORAL PRESS FIT STEM. AFTER DISCUSSIONS WITH THE PATIENT, THE DECISION WAS MADE TO DO A FEMORAL ONLY REVISION - PLAN A BEING TO REVISE THE FEMORAL SLEEVE TO A LARGER SIZE AND REDUCE THE FEMORAL STEM DIAMETER. PLAN B WOULD BE EITHER AN S-ROM HINGE OR LPS DISTAL FEMORAL REPLACEMENT DEPENDING ON BONE QUALITY FOLLOWING REMOVAL OF THE CURRENT ATTUNE REVISION FEMORAL COMPONENTS. THE REMOVAL PROCESS WAS NOT SIMPLE AS THE INITIAL COMPONENTS WERE WELL FIXED, AND AS A RESULT THERE WAS A COMPLETE FRACTURE OF THE LATERAL DISTAL FEMORAL CONDYLE AS WELL AS SIGNIFICANT METAPHYSEAL BONE LOSS OF THE DISTAL FEMUR WHILST ATTEMPTING TO REMOVE THE WELL FIXED SLEEVE AND STEM. PALACOS BONE CEMENT WAS USED IN ALL PROCEDURES. PLAN B WAS ACTIONED AND A LPS DISTAL FEMORAL REPLACEMENT WAS PERFORMED.

  Patient problems: Discomfort; Pain

  MAUDE report 14886472 ↗
• 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 14688461 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO THE INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14218700 ↗
• 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 11569548 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10401803 ↗