ATTUNE 1511-01-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295419587), received between Jan 25, 2019 and May 18, 2026 — classified as 38 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 40 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT PRESENTED IN THE ER WITH POOR FUNCTION AND PAIN. FEMORAL COMPONENT APPEARED TO HAVE ROTATED ROUGHLY 90 DEGREES INTERNALLY. THE STEM, SLEEVE AND LPS ADAPTER WERE PLACED INITIALLY AND LEFT IN PLACE WHEN CONVERTED FROM A SPACER TO A REV TKA USING AN IPS DISTAL FEMUR ON (B)(6) 2026. THERE APPEARED TO BE DAMAGE ON THE TAPER OF THE ADAPTER AND UNFORTUNATELY IT COULD NOT BE REMOVED. THE STEM, SLEEVE AND ADAPTER WERE ALL REMOVED AND NEW COMPONENTS WERE PLACED WITH NO DELAY NOR PATIENT HARM. DOIL: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25205197 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED JOINT INSTABILITY FOLLOWING TOTAL KNEE ARTHROPLASTY REVISION, ATTRIBUTED TO MEDIAL COLLATERAL LIGAMENT (MCL) INSUFFICIENCY. THE SURGEON DETERMINED THAT A HINGE PROSTHESIS WOULD BE REQUIRED TO RESTORE STABILITY. FEMORAL SIDE COMPONENTS WERE REMOVED AND A DISTAL FEMORAL PROSTHESIS WAS PLACED WITHOUT DELAY OR HARM. ALL COMPONENTS WERE WELL FIXED AND PERFORMED AS EXPECTED BUT COULD NOT SUPPORT THE LOSS OF STABILITY POST MCL INSUFFICIENCY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 24732242 ↗
• 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 24051356 ↗
• InjuryNov 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). 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: 20 OCT 2025. DATE OF IMPLANT: ON (B)(6) 2014. DATE OF REVISION: ON (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION - COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL, TRUE), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23547600 ↗
• InjuryOct 23, 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 INFECTED KNEE. SURGEON PERFORMED EXPLANT AND PLACEMENT OF AB SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23372982 ↗
• 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 23099801 ↗
• InjurySep 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE, STEM, AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. REMOVED ALL FEMUR IMPLANTS AND DID NEW. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23016891 ↗
• 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 (B)(4) PER OPTIMIZE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22748287 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF THE FEMORAL KNEE FOR STIFFNESS. COMPONENTS WERE NOT LOOSE OR DAMAGED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 22384928 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM IN (B)(6) WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. DERS WERE SUBMITTED. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND POSSIBLE INFECTION (NOT CONFIRMED AT THAT TIME) AT (B)(6) MEDICAL CENTER. CAPTURED IN (B)(4). AT THE SAME TIME, ON (B)(6) 2025,

  Patient problems: Unspecified Infection

  MAUDE report 21884433 ↗
• 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: 22 NOV 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 20461737 ↗
• 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 20398802 ↗
• 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 19323017 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AFTER THE PATELLA TENDON RUPTURE. NO DELAY PATELLA IS AN IMPLANT AND NOT REMOVED. INSTABILITY NOT RELATED TO POLY WEAR. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18981182 ↗
• InjuryJan 25, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT AT UNKNOWN INTERFACE FROM INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6), 2019 DOR: (B)(6), 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18581533 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS POSITIVE FOR NICKEL ALLERGY AND IS SYMPTOMATIC TO INCLUDE ITCHING, RASHES, AND PAIN. ALL COMPONENTS WERE REMOVED SUCCESSFULLY WITHOUT PATIENT HARM OR DELAY AND A METAL SENSITIVE KNEE REVISION WAS PERFORMED UTILIZING COMPONENTS FROM A DIFFERENT MANUFACTURER. HIS INITIAL KNEE REVISION WAS PERFORMED ON THE DATE LISTED, HOWEVER A TIBIAL SIDE REVISION WAS ALSO PERFORMED ON (B)(6) 2023 DUE TO PAIN. A DER WAS SUBMITTED AT THAT TIME. IT WAS LATER, WHEN HIS PAIN PERSISTED THAT THE METAL ALLERGY TEST WAS PERFORMED AND HIS ALLERGY WAS CONFIRMED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Rash

  MAUDE report 18541807 ↗
• 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 18301787 ↗
• InjuryOct 17, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AND ATTUNE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. PATIENT CAME IN TO ER WITH DISLOCATED DEPUY LPS DISTAL FEMORAL REPLACEMENT. WHILE OPENING TO REVISE, IT WAS ALSO APPARENT THAT THE KNEE WAS INFECTED. ALL IMPLANTS WERE REMOVED EXCEPT THE TIBIA BASEPLATE, TIBIAL SLEEVE AND STEM. ANTIBIOTIC SPACER IMPLANTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17948329 ↗
• 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 17773246 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED LTKA. SURGEON EXPLANTED THE ATTUNE REVISION IMPLANTS WE IMPLANTED ON (B)(6) 2023. THEY WASHED OUT THE KNEE IMPLANTED JUST A ATTUNE REV FEMORAL COMPONENT AND ATTUNE INSERT ALONG WITH SOME ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368289 ↗
• InjuryJul 17, 2023Loss of or Failure to Bond; Off-Label Use; Loss of or Failure to Bond; Off-Label Use

  IT WAS REPORTED THAT PATIENT PRESENTS AT FOLLOW UP WITH PERIPROSTHETIC FX AT DISTAL TIP OF TIBIAL STEM. SURGERY TO ADDRESS FRACTURE AND PLACE A LONGER STEM IN TIBIA TAKES PLACE UNEVENTFULLY AND NO PATIENT HARM OCCURS. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2023; DOR- (B)(6) 2023; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17331718 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY IN FLEXION. DOCTOR DECIDED THAT WE WERE NOT GOING TO BE ABLE TO MAKE A CRS INSERT WORK WITH JUST BALANCING. HE DECIDED A HINGED KNEE WAS NECESSARY. WHILE REMOVING THE ATTUNE SLEEVE HE ENCOUNTERED MORE BONE LOSS THAN HE HOPED AND DECIDED THAT A DISTAL FEMORAL REPLACEMENT WAS NECESSARY. HE WOULD HAVE LIKED TO BE ABLE TO PUT A HINGED KNEE INTO THE ATTUNE REV SLEEVE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16203368 ↗
• 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 15966402 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WITH PREVIOUS ATTUNE KNEE REVISION WAS REVISED DUE TO LIGAMENT LAXITY. WELL FIXED ATTUNE REVISION IMPLANTS REMOVED AND REPLACED WITH A HINGE BEARING. DID THE EVENT OCCUR DURING STERILE PROCESSING? NO. DID THE EVENT OCCUR DURING FIELD INSPECTION? NO. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PATIENT WITH PREVIOUS ATTUNE KNEE REVISION WAS REVISED DUE TO LIGAMENT LAXITY. WELL FIXED ATTUNE REVISION IMPLANTS REMOVED AND REPLACED WITH A HINGE BEARING. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: PATIENT WITH PREVIOUS ATTUNE KNEE REVISION WAS REVISED DUE TO LIGAMENT LAXITY. WELL FIXED ATTUNE REVISION IMPLANTS REMOVED AND REPLACED WITH A HINGE BEARING. IS THE PATIENT PART OF A CLINICAL STUDY? NO. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): D

  Patient problems: Joint Laxity

  MAUDE report 15951346 ↗
• 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 15493798 ↗