ATTUNE 1511-11-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295419624), received between Mar 14, 2019 and Sep 25, 2026 — classified as 24 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904693 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE, AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 23862883 ↗
• InjuryJun 28, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT X-RAYS SHOW PROGRESSIVE LUCENT LINES AND CONTINUES TO COMPLAIN OF PAIN. A POLY EXCHANGE WAS PERFORMED ON (B)(6) 2023 AND A DER WAS SUBMITTED. THE FEMORAL COMPONENT WAS REMOVED WITH EASE AND CEMENT HAD NOT ADHERED TO THE BONE. HOWEVER THE FEMORAL SLEEVE WAS INGROWN AND HAD TO REMOVED UTILIZING SIGNIFICANT EFFORT. THE TIBIAL TRAY WAS WELL FIXED, HOWEVER THE TIBIAL SLEEVE ONLY SHOWED FIBROUS TISSUE, INDICATING THAT IT WAS LOOSE. THE PATELLA WAS ALSO REMOVED QUITE EASILY. THE SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR HIS REVISION PROCEDURES, HOWEVER IT IS HOSPITAL OWNED SO NOT IN ANY OF MY RECORDS. A FULL REVISION OFF ALL COMPONENTS WAS PREFORMED WITH NO DELAY NOR PATIENT HARM. NO WEAR WAS NOTED AND ALL COMPONENTS WERE APPROPRIATELY SIZED AND ALIGNED. DOI: (B)(6) , 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE. (B)(4) CREATED FOR 8TH JUN 2023 REVISION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19632904 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 18713442 ↗
• InjuryNov 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  LOOSE ATTUNE REVISION TIBIA WITH A PARTIAL COATED SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 18140439 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REVISION PROCEDURE IN (B)(6) 2022 AT A DIFFERENT HOSPITAL, PATIENT PRESENTED WITH EVIDENCE OF INFECTION OF HER KNEE JOINT REPLACEMENT AND HAD A DAIR PROCEDURE TO ATTEMPT TO ELIMINATE THE INFECTION ALONG WITH ANTIBIOTIC COVER. THIS UNFORTUNATELY WAS UNSUCCESSFUL AND THE DECISION WAS MADE TO REMOVE ALL IMPLANTS AND REPLACE WITH A TEMPORARY TIBIAL NAIL WHICH BRIDGES ACROSS THE KNEE JOINT WITH ANTIBIOTIC LOADED CEMENT. THE PATIENT WILL RETURN IN 6-8 WEEKS FOR PLANNED KNEE REVISION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 16875584 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE INSERTED ON 2 DIFFERENT DATES AS A PARTIAL REVISION WAS PERFORMED ON THE SECOND DATE, (B)(6) 2021. A DER WAS SUBMITTED AT THAT TIME. FIRST 3 ITEMS LISTED WERE LEFT FROM (B)(6) 2020 PROCEDURE, THE REST WERE PLACED IN MAY 21. PATIENT COMPLAINED OF TIBIAL PAIN. XRAYS APPEARED TO HAVE LUCENCIES ON THE TIBIAL SIDE SO A TIBIAL SIDE REVISION WAS PLANNED. INSERT AND FEMORAL COMPONENT WERE REMOVED FOR EXPOSURE, THEN TIBIAL TRAY AND STEM WERE REMOVED, BUT THE TIBIAL SLEEVE WAS FOUND TO BE WELL FIXED. THE SURGEON WANTED TO SHORTEN THE ADAPTER ON THE FEMORAL SLEEVE AND WHEN TRYING TO REMOVE THE ADAPTER THE FEMORAL SLEEVE AND STEM WERE EXTRACTED. AT THIS POINT, A TIBIAL AND FEMORAL REVISION WERE PERFUMED UNEVENTFULLY. THERE WAS NO PATIENT HARM. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15526017 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF IMPLANT. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REVISION: (B)(6) 2020. (UNKNOWN KNEE). TREATMENT: REMOVAL OF IMPLANT FOR UNKNOWN REASON.

  Patient problems: Unspecified Infection

  MAUDE report 14680632 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE (RIGHT) - CONFIRMATION OF LOOSENING TIBIAL COMPONENT EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: ASPIRATION OF KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 14073470 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE - AS A RESULT OF RAISED CRP AND INFECTION - CONFIRMATION OF LOOSENING TIBIAL COMPONENT? UNCONFIRMED CURRENTLY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: ARTHROSCOPY, ARTHROSCOPIC BIOPSIES TO CONFIRM INFECTED TOTAL KNEE; ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 13939587 ↗
• MalfunctionDec 7, 2021Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE SURGEON WAS IMPACTING THE REVISION TIBIAL COMPONENTS IN THE REVISION TIBIA CONSTRUCT SAT UP SEVERAL MM FROM WHERE THE TRIAL SAT WHEN CEMENTING. HE HAD TO REMOVE TIBIA CLEAR OUT ALL THE CEMENT THAT HE JUST MIXED FOR IMPLANTS BECAUSE IT HARDENED. WE HAD TO OPEN NEW TIBIAL COMPONENTS FOR PATIENT WHICH CAUSED A 35-40 MIN DELAY IN THE CASE. DOI: (B)(6) 2021, DOE: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12954979 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID REVISION SURGERY ON (B)(6) 2019 AT CHA. THE KNEE IS NOW INFECTED SO THE SURGEON REMOVED ALL COMPONENTS AND PUT IN AN ANTIBIOTIC KNEE SPACER. DOI: (B)(6) 2019, DOR: (B)(6) 2021 (RIGHT KNEE).

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

  MAUDE report 12496579 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DEPUY SYNTHES PRODUCT WAS IN THE PATIENT. IT WAS REMOVED SUBSEQUENT THE NOTED INJURY. THEY DO NOT BELIEVE THERE TO HAVE BEEN ANY PRODUCT DEFICIT, HOWEVER AFTER HAVING A OPEN WOULD OVER A JOINT REPLACEMENT, THE SURGEON FELT IT WAS NECESSARY TO REMOVE. EVERYTHING WAS REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Laceration(s); Wound Dehiscence

  MAUDE report 11437168 ↗
• InjuryFeb 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER UNKNOWN. ORIGINAL IMPLANT DATE UNKNOWN. NO DELAY IN SURGERY. DOI: UNK, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11367125 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT HAD A REVISION OF LEFT KNEE ARTHROPLASTY OF BOTH FEMORAL AND TIBIAL COMPONENTS TO ADDRESS MECHANICAL LOOSENING OF LEFT TOTAL KNEE REPLACEMENT, PAIN, SWELLING, AND STIFFNESS. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT BONE/CEMENT INTERFACE. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED, BUT WAS REVISED. COMPETITOR COMPONENTS AND COMPETITOR CEMENTS WERE USED DURING THIS PROCEDURE. DOI: (B)(6) 2017 (FEMUR; PRIMARY SURGERY), DOI: (B)(6) 2018 (INSERT, TIBIA, CEMENT; CAPTURED IN (B)(4)), DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 10929667 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: No Code Available; Pain

  MAUDE report 10575309 ↗
• InjurySep 11, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIA SLEEVES AT THE BONE TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON PERFORMED ONE STAGE REVISION AS PATIENT ASPIRATION GREW OUT (B)(6). ALL COMPONENTS REMOVED AND REPLACED. CEMENT WAS OWNED BY HOSPITAL SO NO INFORMATION WAS AVAILABLE IN OUR RECORDS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 10522683 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10378969 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN FRONT SIDE TARGET KNEE AND LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: ORAL MEDICATION AND SURGICAL KNEE MANIPULATION UNDER ANESTHESIA INTERVENTION (NO REVISION OF PRODUCTS).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10285802 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PNEUMONIA. EVENT IS SERIOUS AND IS CONSIDERED MILD. THE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2018, (RIGHT KNEE). TREATMENT: HOSPITALIZED, WITH INJECTED AND ORAL MEDICATIONS.

  Patient problems: No Code Available

  MAUDE report 10285734 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INSTABILITY OF LATERAL LIGAMENTS. ON (B)(6) 2020, THESE REVISION IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANTS FROM ANOTHER COMPANY. SIDE: LEFT.

  Patient problems: No Code Available

  MAUDE report 10242087 ↗
• InjuryMay 18, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Migration; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Migration

  ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT PRIMARY COMPETITOR KNEE TO TREAT PAIN AND EFFUSION SECONDARY TO ADVANCED DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018: PATIENT RECEIVED A RIGHT REVISION ATTUNE TKA TO TREAT PAIN AND SELLING SECONDARY TO LOOSENING OF A COMPETITOR KNEE SYSTEM. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EVACUATED A SYNOVIAL CYST AND SCAR TISSUE. THE COMPETITOR FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE COMPETITOR TIBIAL TRAY WAS LOOSENED AT THE CEMENT TO IMPLANT AND CEMENT TO BONE INTERFACE, THE CEMENT MANTLE ALONG THE TIBIAL BONE HAD A TRAMPOLINE EFFECT AND THERE WAS A CYST IN THE ANTERIOR TIBIA. THE COMPETITOR PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED COMPETITOR TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2020: PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN SECONDARY TO TIBIAL COMPONENT LOOSENING AND COLLAPSE. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND REMOVED MARKED EFFUSION AND PERIARTICULAR SCAR TISSUE. THE FEMORAL COMPONENT

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Edema; Inadequate Osseointegration; Inflammation; No Code Available; Pain

  MAUDE report 10065851 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF COMPONENTS DUE TO INFECTION, ALL COMPONENTS REMOVED FROM PREVIOUS REVISION CASE DONE ON THE (B)(6) 2020 WHICH WAS THE 2ND STAGE REVISION, 1ST STAGE REVISION COMPLETED ON THE (B)(6) 2019. (B)(6), THIS IS THE 3RD STAGE REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853002 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE PAIN POST TKR REVISION AT TIBIA AND INFLAMMATION OF ITB AT GERDY'S TUBERCLE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2019 (ONSET); (RIGHT KNEE).

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 9396829 ↗
• InjuryMar 14, 2019Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  PATIENT REPORTED WITH PAINFUL AND UNSTABLE RIGHT TKA FROM AN OUTSIDE HOSPITAL WITH NO AVAILABLE OPERATIVE REPORT. XRAYS INDICATED A SUBSIDED AND LOOSE TIBIAL COMPONENT WITH A STEM EXTENSION APPEARING TO HAVE EXITED THE LATERAL TIBIAL CORTEX. THE SURGICAL PLAN WAS TO RETAIN THE WELL-FIXED FEMORAL COMPONENT AND REVISE ONLY THE TIBIAL COMPONENT AND INSERT. UPON EXPLANTING THE TIBIAL COMPONENT CONSTRUCT IT BECAME EVIDENT THAT THE COMPONENT WAS PREOPERATIVELY MISIDENTIFIED BY THE SURGICAL TEAM AS AN MBT REVISION TIBIA AND WAS ACTUALLY AN ATTUNE REVISION COMPONENT. NO INSTRUMENTS OR IMPLANTS WERE IMMEDIATELY AVAILABLE FOR THE ATTUNE SYSTEM. THE ATTENDING SURGEON, WHILE BEING ADVISED OF THE OFF-LABEL NATURE OF HIS DECISION, DECIDED IT WAS IN THE BEST INTERESTS OF THE PATIENT TO IMPLANT A SIGMA MBT REVISION RP 15MM BUILDUP TRAY AND TO MODIFY AND UTILIZE A SIGMA TC3 RP REVISION INSERT TO ARTICULATE WITH THE SIZE 3 ATTUNE REVISION FEMORAL COMPONENT WHICH RESULTED IN A STABLE OVERALL CONSTRUCT.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8420561 ↗