ATTUNE 1513-12-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295043553), received between Sep 10, 2018 and Aug 4, 2026 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

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

  It was reported that patient was draining and surgeon elected to wash out and change components.DOI: On (b)(6) 2026.DOR: On (b)(6) 2026.Affected Side: Right.

  Patient problems: Fluid Discharge

  MAUDE report 50129656 ↗
• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THESE PRODUCTS IMPLANTED ON (B)(6) 2026. LATER THAT NIGHT IN THE PACU SHE SUSTAINED A KNEE DISLOCATION, REASONS UNKNOWN. THERE WAS NO EVENT THAT TRIGGERED IT. ACCORDING TO THE DR. ¿IT JUST SORT OF HAPPENED WITHOUT AN INCIDENT. THE DR STATS THAT THE PATIENT HAS A HISTORY OF COMPROMISED SOFT TISSUES OF THE LEFT KNEE. SO, THE DR EXPLANTED ALL COMPONENTS AND IMPLANTED A HINGE KNEE REVISION PROSTHESIS. DOI-(B)(6) 2026. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25853232 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED DUE TO INFECTION AND WASH OUT. THERE WAS NO HARM DONE TO THE PT. NOR DELAY TO THE CASE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25042344 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH DRAINING POST REVISION TKA THAT WAS TREATED WITH A STATIC SPACER FOR INFECTION. WHILE ASPIRATION PRIOR TO REIMPLANTATION WAS NEGATIVE FOR INFECTION, PATIENT NOW WAS POSITIVE FOR A FUNGAL INFECTION AND ALL COMPONENTS WERE REMOVED AN A NEW STATIC SPACER WAS PLACED IN CONJUNCTION WITH RESORBABLE ANTIBIOTIC BEADS LOADED WITH ANTIBIOTIC AND ANTIFUNGAL MEDICATION. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24834941 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR INFECTION. SURGEON REMOVED PROSTHESIS PUT IN TEMPORARY SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24486587 ↗
• InjuryFeb 24, 2026Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 26 JAN 2026. DATE OF IMPLANT: (B)(6) 2008. DATE OF REVISION: (B)(6)2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: KNEE REPLACEMENT; WERE DEPUY SYNTHES COMPONENTS REMOVED? YES, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440108. LOT NUMBER: MC4462. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 8 LEFT CEMENTED. CATALOG NUMBER: 150660006. LOT NUMBER: 4986915. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG NUMBER: 151710810. LOT NUMBER: 9927060. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 8 10MM. CATALOG NUMBER: 151214050. LOT NUMBER: D25093258. COMPONENT TYPE: STEM. DESCRIPTION: ATTUNE REVISION CEMENTED STEM 14 MM X 50 MM. CATALOG NUMBER: 545050501. LOT NUMBER: 4989849. COMPONENT TYPE: CEMENT. DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 151111203. LOT N

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430881 ↗
• 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 24258561 ↗
• 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.

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

  MAUDE report 24165793 ↗
• InjuryJan 6, 2026Fracture

  IT WAS REPORTED THAT THE LPS FEMUR EXPLANTED DUE TO STEM BREAKING OFF FROM SLEEVE. IT WAS STATED THAT SLEEVE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 23977173 ↗
• 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 23592581 ↗
• 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 23547684 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 15 SEP 2025, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: ON (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23325190 ↗
• InjuryAug 25, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAS A PERSISTENT INFECTION POST TKA UTILIZING REVISION COMPONENTS DUE TO EXTREME DEFORMITY. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS FOLLOWING A THOROUGH DEBRIDEMENT. RESORBABLE ANTIBIOTIC BEADS WERE ALSO PLACED. PATIENT HAS HAD MULTIPLE I&DS FOLLOWING THIS PROCEDURE AND DERS WERE SUBMITTED FOR EACH. POROUS COMPONENTS DID NOT SHOW INGROWTH, SUGGESTING THAT THE INFECTION HAS BEEN PRESENT THROUGHOUT CARE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 22883710 ↗
• InjuryAug 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT'S PRIMARY KNEE WAS DONE. THE PATIENT BEGAN TO HAVE PAIN IN TIBIA. UPON LOOKING AT XRAYS, THE SURGEON DETERMINED THE TIBIAL STEM WAS THROUGH THE LATERAL CORTEX. THE PATIENT UNDERWENT REVISION SURGERY. THE ENTIRE TIBIAL COMPONENT AND POLY WAS REMOVED, A TOTAL OF FIVE IMPLANTS. AFFECTED SIDE: RIGHT KNEE

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 22784619 ↗
• InjuryJun 17, 2025Migration; Migration

  IT WAS REPORTED A REVISION OF A LEFT KNEE OCCURRED ON (B)(6) 2025 WHERE AN ATTUNE IMPLANT WAS EXPLANTED. THE IMPLANTS BOTH SIDE WERE LOOSE AND THE TIBIAL STEM HAD MIGRATED OUTSIDE OF THE TIBIAL BONE. ORIGINAL IMPLANT WAS DONE IN 2021. THE ATTUNE REVISION IMPLANTS REMOVED HAD NO BONE ON GROWTH ON THE FEMORAL METAPHYSEAL SLEEVE AND LIMITED ON THE TIBIAL METAPHYSEAL SLEEVE. THE POLY HAD TO BE SPLIT FOR REMOVAL PURPOSES BUT WAS INTACT AT TIME OF REVISION. THE SURGEON STATED THERE WAS NO INFECTION PRESENT. SURGEON SUSPECTS REACTION TO THE METAL. THE PATIENT WAS REVISED TO ANOTHER COMPANY'S IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 22236111 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Physical Asymmetry

  MAUDE report 19033339 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS IN JOINT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: ON (B)(6) 2017, DATE OF EVENT: UNK JAN 2018, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, ORAL MEDICATION, AND PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 16451999 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16213885 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493964 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, ON (B)(6) 2022, ALL THE IMPLANTS WERE REMOVED. AT FIRST, THE SURGEON PLANNED TO REMOVE THE INSERT, REPLACED AND CLEANSED; HOWEVER, THE IMPLANTS WERE LOOSENED. CONSEQUENTLY, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED CEMENT MOLD. ACCORDING TO THE SURGEON, THE PATIENT HAD DIABETES AND WAS NOT WELL CONTROLLED. NO FURTHER INFORMATION IS AVAILABLE. DOI: MARCH 23, 2021. DOR: JULY 12, 2022. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15113050 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NEUROLOGICAL PAIN NERVUS INFRAPATELLARIS LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2022; (LEFT KNEE). TREATMENT: NEURECTOMY NERVUS INFRAPATELLARIS.

  Patient problems: Pain

  MAUDE report 13653186 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PREVIOUSLY REVISED KNEE WAS REVISED A SECOND TIME DUE TO PAIN AND INSTABILITY. THE PATIENT'S ATTUNE REVISION KNEE COMPONENTS WERE REMOVED AND REPLACED BY AN S-ROM NOILES HINGED FEMUR, AN LPS HINGED RP INSERT, AND A SIGMA REVISION MBT TIBIAL TRAY. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WOULD HAVE BEEN USED IN THE PRIOR REVISION PROCEDURE, SINCE THE HOSPITAL ONLY STOCKS SMARTSET CEMENT. THE PRODUCT CODES AND LOT NUMBERS FOR THE CEMENT IS NOT AVAILABLE, SINCE THE CEMENT USED WAS HOSPITAL INVENTORY ORDERED DIRECTLY FROM DEPUY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13170667 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE LEFT SIDE. SURGERY TIME WAS NOT EXTENDED.

  Patient problems: Pain

  MAUDE report 12883491 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: ORAL MEDICATION (UNSPECIFIED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12167509 ↗
• InjuryJun 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TROCHANTERIC BURSITIS, HIP AND KNEE PAIN AND CREPITUS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED) AND PHYSICAL THERAPY.

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

  MAUDE report 12073124 ↗