ATTUNE 1511-06-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295503392), received between Oct 28, 2021 and Jun 18, 2026 — classified as 21 injuries.

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS STILL INFECTED. THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW COMPONENTS. DOI: UNKNOWN DOR: (B)(6) 2026 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25553625 ↗
• 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 24258418 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTS WITH INFECTION POST SPACER. HOWEVER, PATIENT NOW PRESENTS WITH A FUNGAL INFECTION. ALL COMPONENTS PERFORMED AS EXPECTED AND WERE WELL FIXED, HOWEVER HAD TO BE REMOVED TO TREAT THIS NEW FINDING. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND AFTER A THOROUGH DEBRIDEMENT, THE BONE WAS PREPARED FOR NEW COMPONENTS. DURING DEBRIDEMENT, A VESSEL WAS PERFORATED DUE TO SCAR TISSUE AND WAS REPAIRED OPERATIVELY. THE SURGEON STATED THIS TO BE A COMMON OCCURRENCE DUE TO THE LOCATION OF DEBRIDEMENT ANATOMICALLY AND WAS EXPECTED AND PREPARED FOR. THIS RESULTED IN A SHORT DELAY WHILE THE REPAIR TOOK PLACE. NEW COMPONENTS WERE PLACED UNEVENTFULLY FOR A NEW SPACER, ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS, ANTIFUNGAL BEADS AND HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 24164273 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN (B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051347 ↗
• 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 23730107 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4) WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697827 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4), WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697823 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNFORTUNATELY, THE PATIENT WAS STILL INFECTED AND DRAINED SO THE SPACER WAS BEING EXCHANGED IN HOPES TO CLEAR THE INFECTION. NO DELAY NOR PATIENT HARM WAS NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 23592551 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRAINAGE SUGGESTING HE WAS STILL INFECTED. ALL WELL FIXED, WELL ALIGNED COMPONENTS WERE REMOVED. A THOROUGH DEBRIDEMENT WAS PERFORMED. BONE WAS THEN PREPARED FOR NEW IMPLANTS WHICH ARE PLACED WITH HIGH DOSE ANTIBIOTIC CEMENT ALONG WITH RESORBABLE BEADS THAT CONTAINED BOTH ANTIFUNGAL AND ANTIBIOTICS. NO DELAY WAS NOTED. PREVIOUS CEMENT WAS DEPUY 2 WITH GENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23099804 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASPIRATED LAST WEEK AND IS NOW GROWING YEAST. ALL COMPONENTS WERE REMOVED IN A ONE STAGE REVISION AND NEW COMPONENTS WERE PLACED AFTER A THOROUGH I&D AND PLACEMENT OF RESORBABLE BEADS CONTAINING ANTIBIOTICS AND AN ANTIFUNGAL AGENT. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED HOWEVER THE FEMORAL SLEEVE HAD FAILED TO INGROW, LIKELY DUE TO THE FUNGUS BEING PRESENT. TIBIAL COMPONENT AND CEMENTED STEM WERE PLACED ON THE ABOVE LISTED DATE. FEMORAL COMPONENTS AND INSERT HAD BEEN REVISED ON (B)(6) 2025 FOR CONTINUED INFECTION. A DER WAS FILED UNDER 1875689 PER OPTIMIZE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22748338 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688981 ↗
• InjuryMay 13, 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 PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22011867 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM WAS THE INFECTION CLEARED. UNKNOWN. LITTLE TO NO WAY TO CONFIRM OR RULE OUT INFECTION DURING A PROCEDURE. TISSUES LOOKED GOOD AT THE TIME OF SURGERY, HOWEVER, DUE TO PREVIOUS CONFIRMED INFECTION, IT WAS TREATED AS IF STILL INFECTED. B. WAS THE STEM LOOSE AS WELL? WHICH SLEEVE WAS LOOSE? FEMORAL STEM WAS ALSO LOOSE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18517767 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CONFIRM WAS THE INFECTION CLEARED. UNKNOWN. LITTLE TO NO WAY TO CONFIRM OR RULE OUT INFECTION DURING A PROCEDURE. TISSUES LOOKED GOOD AT THE TIME OF SURGERY, HOWEVER, DUE TO PREVIOUS CONFIRMED INFECTION, IT WAS TREATED AS IF STILL INFECTED. B. WAS THE STEM LOOSE AS WELL? WHICH SLEEVE WAS LOOSE? FEMORAL STEM WAS ALSO LOOSE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18517702 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME INTO TO ER AND WAS ADMITTED FOR SUSPECTED INFECTION POST REV TKA. A SINGLE STAGE REVISION KNEE WAS PERFORMED UTILIZING A DUAL SET-UP AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. CEMENTED COMPONENTS WERE WELL FIXED LEFT IN PLACE. NO PATIENT HARM OCCURRED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17821143 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTS OF SURGICAL DELAYS.

  Patient problems: Adhesion(s); Discomfort; Joint Contracture; Loss of Range of Motion

  MAUDE report 17540194 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO BONE RESORPTION AT THE INTERFACE OF THE FEMORAL SLEEVE AND DISTAL FEMUR. SURGEON WAS CONCERNED THAT FURTHER BONE LOSS COULD LEAD TO A FRACTURE OF THE DISTAL FEMUR AND DECIDED TO REVISE THE FEMORAL SIDE OF THE CONSTRUCT. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Unspecified Tissue Injury

  MAUDE report 17396281 ↗
• 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 PT 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 15397921 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REMAINS INFECTED. ALL COMPONENTS WERE REMOVED AND A SPACER WAS FASHIONED UTILIZING LPS COMPONENTS. CEMENT WAS DEPUY 2 WITH GENT BUT NO QUANTITY OR LOT INFORMATION IS AVAILABLE AS IT IS HOSPITAL OWNED INVENTORY. IT WAS ALSO REPORTED THAT TIBIAL AND FEMORAL COMPONENTS WERE LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14207968 ↗
• 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 13536189 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CEMENT IS HOSPITAL INVENTORY SO NO PART, LOT OR QUANTITY IS AVAILABLE IN MY RECORDS. SURGEON ROUTINELY USES DEPUY 2 WITH GENT IN HIS REVISION PROCEDURES. B. (B)(6) 2020. C. LOOSENING IS UNEXPLAINED. THE SURGEON SUSPECTED INFECTION BUT CULTURES WERE NOT POSITIVE FOR INFECTION.

  Patient problems: Blister; Unspecified Infection

  MAUDE report 12712245 ↗