ATTUNE 1511-11-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295436577), received between Oct 22, 2019 and Apr 9, 2026 — classified as 31 injuries, 1 malfunction.

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 32 reports, in the reporter's own words as published by the FDA.

• 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 24834933 ↗
• 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 24257955 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054171 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT STIFFNESS WITH ESSENTIALLY NO MOTION POST REVISION TKA FOR STIFFNESS. SURGEON IS NOT SURE WHY PATIENT IS SO STIFF AS NO INFECTION IS PRESENT BASED ON LABS AND FROZEN SECTION. ALL COMPONENTS WERE REMOVED. FEMORAL SLEEVE WAS NOT INGROWN ALMOST 5 MONTHS POST OP. THERE WAS NO RADIOGRAPHIC INDICATION THAT COMPONENT WOULD BE LOOSE. TIBIAL COMPONENTS WERE SUBSEQUENTLY REMOVED TO LOWER THE JOINT LINE AS THE PATELLA WAS IMPINGING THE INSERT AFTER REVISING THE FEMUR. THIS IS LIKELY A RESULT OF SHORTENING OF THE PATELLAR TENDON DUE TO LACK OF MOTION. TIBIAL SLEEVE WAS ONLY PARTIALLY INGROWN. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23709339 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607654 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. 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: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23325702 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22948042 ↗
• InjuryJul 2, 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. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22387113 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4). DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329952 ↗
• InjuryFeb 19, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING ON THE BONE IMPLANT AND BONE/CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21414553 ↗
• InjuryFeb 3, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION DONE IN 2021. THE TIBIAL COMPONENTS BECAME LOOSE AND THE PATIENT WAS BROUGHT IN FOR TIBIAL COMPONENTS REVISION. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21294392 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? -NO. B. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS -NO.

  Patient problems: Unspecified Infection

  MAUDE report 20492414 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: (B)(6) 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461905 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED LEFT KNEE. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20398804 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352235 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION 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) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: CLINICAL NOTIFICATION INDICATES, THE PATIENT UNDERWENT A I&D WITH ASPIRATION AND DRAINAGE. AND RECEIVED INJECTED MEDICATION AND ORAL ANTIBIOTICS FOR TREATMENT OF INFECTION. NO IMPLANTS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 20071399 ↗
• InjuryOct 18, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF ATTUNE REVISION TIBIAL TRAY, SLEEVE AND STEM DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17960147 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2021; (LEFT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 17773195 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE REVISION REMOVAL DUE TO A POST OP FIXED FLEXION DEFORMITY FROM THE ORIGINAL REVISION SURGERY ON THE (B)(6) 2021 WITH A FOLLOWING SURGERY FOR A POLY REVISION ALSO DONE ON (B)(6) 2022 TO SEE IF WE DOWNSIZED THE POLY IF THAT WOULD HELP THE DEFORMITY. PATIENT WAS VERY UNHAPPY (ALSO NOT A COMPLIANT PATIENT WITH POST OP RECOVERY).

  Patient problems: Loss of Range of Motion

  MAUDE report 15994871 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: INJECTED MEDICATION (CORTISONE).

  Patient problems: Pain

  MAUDE report 15966216 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS REMOVED AND REPLACED DUE TO SUSPECTED INFECTION. IMPLANTS WERE PLACED ON 2 DATES PER THE RECORDS, 9-12-19(FIRST 5 ITEMS LISTED) AND 1-27-22. PATIENT EXPERIENCED REPEATED EFFUSIONS. SURGEON HAS SENT MULTIPLE ASPIRATIONS BUT NO CULTURES WERE NOT POSITIVE. CELL COUNTS AND LAB VALUES WERE ELEVATED, BUT NOT REACHING A LEVEL TO DIAGNOSE INFECTION. DURING THE PROCEDURE, 2 SEPARATE TISSUE SAMPLES WERE SENT TO PATHOLOGY, AND 3 AND 4 WBC/HPF WERE FOUND, AGAIN ELEVATED BUT NOT DEFINITIVE. SURGEON CHOSE TO REMOVAL ALL COMPONENTS AND REPLACE IN A ONE STAGE FASHION AFTER A THOROUGH DEBRIDEMENT AND IRRIGATION. ANTIBIOTIC BEADS WERE PLACED IN CANALS AND SURROUNDING SOFT TISSUES AND VANCOMYCIN WAS ADDED TO GENT CEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15443153 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS A COMPETITOR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15347436 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR INFECTION, PATIENT HAD BEEN REVISED FOR INFECTION IN THE PAST.

  Patient problems: Unspecified Infection

  MAUDE report 15191242 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND LOOSENING. IT IS UNKNOWN WHICH PRODUCTS AND INTERFACES WERE LOOSE.

  Patient problems: Pain

  MAUDE report 13791980 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STILL PRESENTING SIGNS OF INFECTION. SURGEON DECIDED TO PERFORM A WASH OUT AND REMOVE IMPLANTS AND REPLACED WITH NEW IMPLANTS. THERE WERE NO INSTRUMENTS BROKEN AND NO SURGICAL TIME ADDED TO CASE. THERE WAS NO NEW INFORMATION THAT THE SALES REP CAN PROVIDE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13357976 ↗