ATTUNE 1511-11-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10603295436560), received between Sep 10, 2018 and Jun 15, 2026 — classified as 72 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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 75 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: AUGUST 10, 2023. DOR: MAY 20, 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Notching; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25503653 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327408 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THE RP BEARING WAS IN BACKWARD. IT IS UNKNOWN IF IT WAS IMPLANTED THIS WAY OR IT ROTATED INTO THAT ORIENTATION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24161017 ↗
• InjuryNov 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(4). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION ¿ ASEPTIC LOOSENING DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION - COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL, TRUE), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23547682 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404484 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL CONSTRUCT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT ONE STAGE REVISION DONE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23391028 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022, A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL-FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED IN (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011424 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22852967 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES, SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828043 ↗
• 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. 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 22772394 ↗
• InjuryJul 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22621487 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. -INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024. - AN I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND DER (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22372909 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105347 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST KNEE REPLACEMENT AND HAD A PERIPROSTHETIC FRACTURE. IN A SEPARATE SURGERY, THEY ADDED A DISTAL FEMUR CONDYLAR PLATE. PATIENT FELL AGAIN, AND BROKE PROXIMAL TO THE PLATE. THE PLAN WAS TO REMOVE THE FEMUR AND USE A DISTAL FEMUR REPLACEMENT. HOWEVER THE PATIENT HAS AN ACTIVE KNEE INFECTION, AND PUSS WAS IN THE SURGERY SITE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 21962845 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: HOSPITALIZATION (INITIAL OR PROLONGED): YES: NO. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: NO: YES.

  Patient problems: Abscess

  MAUDE report 20831785 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AS PER SURGEON. THE PATIENT, HAD NICKEL ALLERGY. SURGEON REMOVED ALL COMPONENTS AND PUT IN COMPETITOR'S NICKEL FREE IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20831285 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 15 JAN 2019, DATE OF IMPLANT: (B)(6) 2019 , DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20507013 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTS WERE REMOVED DUE TO INFECTION. A SPACER WAS PLACED UTILIZING LPS COMPONENTS IN A DUAL SET UP FASHION IN CONJUNCTION WITH A THOROUGH I&D WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY NOR PATIENT HARM TOOK PLACE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS AT THIS TIME, AS ALL WERE WELL FIXED AND WELL FUNCTIONING. FEMORAL SIDE HAD BEEN REVISED ON (B)(6) 2023 AND AGAIN ON (B)(6) 2024. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20426489 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO BE REINFECTED AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED, AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT; THEY WERE SIMPLY REMOVED DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE PER THAT SYSTEM. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928261 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SYMPTOMS OF INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH I&D PERFORMED AND A ACER WAS FASHIONED OF LPS COMPONENTS. NO DELAY NOR PATIENT HARM WAS NOTED. ALL COMPONENTS WERE WELL FIXED AND INGROWN. PATIENT DID HAVE A COMPONENT EXCHANGE WITH I&D PERFORMED ON (B)(6) 2024 DUE TO A FALL. (B)(4) WAS FILED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19809845 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT: ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO PAIN, AND DEBONDING AT THE COMPETITOR TIBIAL TRAY AND DEPUY CEMENT INTERFACE. (B)(4) . AT REVISION, DEPUY COMPONENTS WERE IMPLANTED AT THAT TIME. DOI: (B)(6) 2021, DOR: (B)(6) 2022 , (B)(4). AFFECTED SIDE: RIGHT KNEE. (B)(4). IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN/SWELLING AND IS LOOKING AT ANOTHER REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19323118 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI- (B)(6) 2024 DOR- (B)(6) 2024 AFFECTED SIDE- LEFT KNEE

  Patient problems: Pain

  MAUDE report 19166961 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. STATING, THAT THE PATIENT HAD A REVISION AND ALL WENT WELL. THE IMPLANT LOOKED GOOD AND NO SPECIAL SIGNS WERE VISIBLE. THE IMPLANTS WENT OFF TO HOSPITAL (B)(6), FOR SONIFICATION AND ARE NOT AVAILABLE ANYMORE. THE PATIENT DID GET A CEMENT SPACER AS A TEMPORARY REPLACEMENT INCLUDING ANTIBIOTIC TREATMENT AND WILL GET A NEW IMPLANT SOON. AT THE MOMENT, IT WILL BE AN IMPLANT FROM A DIFFERENT PROVIDER.

  Patient problems: Unspecified Infection

  MAUDE report 18414027 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTED KNEE POST REVISION TOTAL KNEE ARTHROPLASTY. ALL COMPONENTS WERE WELL ALIGNED, WELL FIXED AND APPROPRIATELY SIZED BUT WERE REMOVED DUE TO INFECTION. A ONE STAGE DUAL SET UP REVISION WAS PERFORMED WITH THOROUGH DEBRIDEMENT AND IRRIGATION AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. NO DELAY WAS ENCOUNTERED AND NO PATIENT HARM OCCURRED. THERE WERE TWO DATES OF IMPLANTATION AS THE PATELLAR COMPONENT WAS RETAINED FROM THE PRIMARY TOTAL KNEE ARTHROPLASTY ON (B)(6), 2022. ALL OTHER COMPONENTS LISTED WERE PLACED (B)(6), 2023. THE CEMENT UTILIZED WAS HOSPITAL INVENTORY AND AS SUCH WAS NOT AVAILABLE IN THE RECORDS. DOI: (B)(6), 2022 (PATELLAR COMPONENT). DOI: (B)(6) 2023 (ALL OTHER COMPONENTS). DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18301942 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:(B)(6) 2020. DATE OF EVENT: 16 MAY 2021; (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, DIAGNOSTIC INVENTION.

  Patient problems: Pain

  MAUDE report 18209062 ↗