ATTUNE 1504-00-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295041290), received between Oct 5, 2017 and Jul 22, 2025 — classified as 38 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS IN OFFICE POST FALL ROUGHLY 6 WEEKS PRIOR POST TOTAL KNEE. SHE NOW COMPLAINS OF PAIN AND INSTABILITY. PHYSICAL EXAM LED SURGEON TO BELIEVE SHE HAD RUPTURED HER MCL AT THE TIME OF FALL AND SHE IS SCHEDULED FOR A REVISION TO ADDRESS. PATIENT HAD BEEN DOING WELL PRIOR TO THE STATED FALL AND WAS VERY HAPPY WITH HER KNEE PRIOR TO THE FALL. PATIENT IS MORBIDLY OBESE AND IS CONSIDERED A CONTRIBUTING FACTOR. DURING SURGERY, THE MCL WAS CONFIRMED TO BE DEFICIENT, ESPECIALLY AT HER SIZE, AND WELL FIXED AND WELL ALIGNED COMPONENTS WERE REMOVED AND A HINGED KNEE CONSTRUCT WAS PLACED WITH NO DELAY NOR PATIENT HARM. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 22565380 ↗
• InjuryJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. ALL IMPLANTS WERE LOOSE AT THE CEMENT/IMPLANT INTERFACE AND DEPUY CEMENT WAS USED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21211282 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR : OTHER SURGICAL SITE / DELAYED WOUND HEALING. ON (B)(6) 2024, MEDICAL RECORDS NOTE THAT THE PATIENT IS NOW 6 WEEKS OUT FROM RIGHT KNEE. CLINICAL IMPRESSION IS THAT THE PATIENT IS DOING WELL. IT WAS NOTED THAT THE PATIENT HAS A LOT OF ADIPOSE TISSUE BELOW THEIR KNEE. ON (B)(6) 2024 MEDICAL RECORDS NOT THE PATIENT¿S CHIEF COMPLAINT IS WOUND CARE, FOLLOW-UP STATUS POST KNEE ARTHROPLASTY. THE PATIENT IS ON ANTIBIOTICS, THE PATIENT HAS THREE AT LEAST THREE POCKETS IN THE WOUND AND ONE IS DRAINING PUS. THE PATIENT HAD A DEBRIDEMENT WITH SCALPEL IN THE OFFICE. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE WOUND. PHYSICAL EXAMINATION NOTES THERE ARE TWO NECROTIC AREAS AT THE DISTAL PORTION OF THEIR INCISION. THE PLAN IS FOR THE PATIENT TO HAVE DEBRIDEMENT AND WOUND VAC PLACEMENT. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE SUPERFICIAL AND DRAINAGE. STATUS POST SUPERFICIAL I AND D OF THE RIGHT KNEE ALONG WITH WOUND VAC PLACEMENT, DOING WELL.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Purulent Discharge

  MAUDE report 20737661 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ON (B)(6) 2024. THE PATIENT UNDERWENT A PRIMARY SURGERY WITH ATTUNE FOR KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, IT WAS CONFIRMED, THAT THE PATIENT WAS INFECTED. CLEANSING WAS PERFORMED. AND THE INSERT WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20707340 ↗
• InjuryOct 25, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMS THAT DEPUY CEMENT WAS NOT USED DURING PRIMARY SURGERY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20533994 ↗
• InjuryJul 2, 2024Adverse 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) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19657365 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED POST TKA FOR INFECTION. SURGEON CHOSES TO PERFORM A ONE STAGE REVISION TKA WITH A DUAL SET UP AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. ALL WELL FIXED WERE COMPONENTS REMOVED AND A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED PRIOR TO PREPPING FOR NEW COMPONENTS. A PORTION OF THE THE ANTERIOR TIBIA CAME OFF WHEN THE TIBIA COMPONENT WAS REMOVED HOWEVER THE SLEEVE HAD GOOD FIXATION WHEN PREPARED. NO DELAY WAS EXPERIENCED. THERE WAS NO LOOSENING BUT DEPUY CEMENT HAS BEEN USED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19361813 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISTAL FEMUR FRACTURE THAT DID NOT HEAL CORRECTLY. SURGEON HAD TO TAKE OUT THE PLATE AND SCREWS AND REVISE. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023 DOR:(B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 19087715 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR (B)(6) REVISED AN ATTUNE PRIMARY TODAY FOR INSTABILITY. HE DID NOT DO THE PRIMARY CASE AND REVISED WITH ZIMMER SO NONE OF OUR PRODUCTS WERE USED. DR (B)(6) STATED THE INDEX SURGERY LIKELY TOOK TOO MUCH OFF THE DISTAL FEMUR WHICH LED TO TIGHT FLEXION AND LOOSE EXTENSION GAPS. HE STATED IT WAS TECHNIQUE RELATED NOT IMPLANT RELATED. THE PRIMARY PROCEDURE WAS DONE BY DR (B)(6) ON THE (B)(6) 2020 BUT UNKNOWN HOSPITAL. I DO NOT HAVE THE LOT NUMBERS AS WE COULD NOT READ THEM, WILL TRY TO GET DETAILS FROM CUSTOMER SERVICE.

  Patient problems: Joint Laxity

  MAUDE report 15873627 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND ARTICULATING SPACER WAS PLACED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15282180 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. THE CEMENT MANUFACTURER WAS COMPETITOR'S. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15183610 ↗
• InjuryJun 3, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REVISION COMPLETED DUE TO LOOSENING. PATIENT STARTED TO COMPLAIN OF PAIN AFTER INITIAL SURGERY. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE TIBIAL COMPONENT WAS LOOSE. SURGEON ALSO SUSPECTS THE FEMORAL COMPONENT MAY HAVE BEEN OVER SIZED, AND THAT THE PATELLA WAS OVER STUFFED. ALL COMPONENTS WERE REVISED TO AN ATTUNE REVISION. CEMENT FOR THE PRIMARY TKR WAS SMARTSET GMV (INCLUDED IN THE IMPACTED PRODUCT SECTION OF THIS REPORT). DOI: (B)(6) 2017; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14590943 ↗
• MalfunctionMar 1, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE FEMORAL COMPONENT, THE SURGEON APPLIED CEMENT TO POSTERIOR CONDYLES. AS THE ASSISTANT WAS READY TO HAND UP IMPLANT TO BE INSERTED, IT WAS NOTED THAT THERE WAS A SUBSTANCE ON THE POLISHED SURFACE OF THE ANTERIOR FLANGE OF FEMORAL COMPONENT. THEN ATTEMPTED TO REMOVE/WIPE OF SUBSTANCE AS IT WAS THOUGHT TO BE CEMENT. HOWEVER, IT WOULD NOT COME OFF. A NEW FEMORAL COMPONENT WAS OPENED AND IMPLANTED WITH NO DELAY OR OTHER COMPLICATIONS. THE FIRST FEMORAL COMPONENT WAS THEN INSPECTED, THE SURGEON, AND ASSISTANT AND APPEARED TO BE THE FOAM FROM PACKAGING THAT WAS STUCK ON COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636078 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY OF THE KNEE. IMPLANTS WERE REMOVED AND REPLACED. DOI : UNKNOWN, DOR : (B)(6) 2022 , RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 13334327 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS POSTERIOR SOFT TISSUE STRETCHING RESULTING IN KNEE HYPEREXTENSION OF 20 DEGREES. THE FEMORAL COMPONENT AND BEARING WERE REVISED TO A HINGED FEMORAL COMPONENT AND HINGED BEARING.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 13053864 ↗
• InjuryDec 7, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED DUE TO GROSSLY LOOSENING OF THE FEMUR COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. MEDIAL CONDYLE HAD COLLAPSED. POLY AND FEMORAL COMPONENT WERE REMOVED. AN ATTUNE REV CONSTRUCT WITH PRESSFIT SLEEVE, STEM, AUGMENTS AND REV FEMUR WERE IMPLANTED WITH A PS FB POLY. DOI: (B)(6) 2017; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12950841 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR BEARING DISLOCATION, (SPIN OUT). FEMORAL COMPONENT CHANGED TO PS ATTUNE AND 1MM THICKER PS BEARING. BEARING WAS VERY DIFFICULT TO DISLOCATE DURING REVISION SURGERY ONCE REDUCED. PRIMARY IMPLANTED BY SURGEON (B)(6) 2021 (B)(6) HOSPITAL. DOI: (B)(6) 2021. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12513665 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) MEDICAL RECORDS AD 27 AUG 2021 WERE REVIEWED. ON (B)(6) 2016, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS END-STAGE OSTEOARTHRITIS, MAINLY INVOLVING PATELLOFEMORAL JOINT. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE UTILIZED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL ARTHROPLASTY TO ADDRESS ASEPTIC LOOSENING. THE FEMORAL, TIBIAL TRAY, INSERT, AND PATELLA WERE REVISED. THE PATIENT WAS NEGATIVE FOR INFECTION. DURING THE PROCEDURE THE SURGEON OBSERVED MODERATE AMOUNT OF SYNOVITIS AS WELL AS SCAR TISSUE. THE INSERT SHOWED NO SIGNIFICANT WEAR BUT WAS REVISED. THE TIBIAL TRAY WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE FEMORAL COMPONENT WAS NOT LOOSE TO PALPITATION, BUT FAIRLY QUICKLY LOOSENED AFTER USING A SAW BLADE AND OSTEOTOMES. THE PREOPERATIVE BONE SCAN RESULTS SHOWED THE PATELLA AS LOOSE. THE PATELLA WAS REMOVED FOR CONCERNS OF LOOSENING, BUT NO LOOSENING WAS NOTED DURING THE PROCEDURE. COMPETITOR COMPONENTS WERE IMPLANTED, INCLUDING COMPETITOR PATELLA AND COMPETITOR CEMENT X3. DOI: (B)(6) 2016, DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Adhesion(s); Synovitis

  MAUDE report 12489537 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020; DATE OF EVENT: (B)(6) 2021; DATE OF REVISION: (B)(6) 2021 ; (RIGHT KNEE). TREATMENT: REVISION OF FEMORAL, TIBIAL AND INSERT COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 12245468 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE MEDIAL EPICONDYLE BONE FRACTURE - FEMORAL . A SMALL INSIGNIFICANT MEDIAL EPICONDYLAR AVULSION OF ANTERIOR MEDIAL EPICONDYLE WITHOUT COMPROMISE OF MCL AND WITH NO STRUCTURAL SIGNIFICANCE. IT IS SECONDARY TO OSTEOPENIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO THE DEVICE AND/OR THE PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (RIGHT KNEE). TREATMENT: ORIF - FIXATION OCCURRED DURING PRIMARY SURGERY. NO ADDITIONAL INTERVENTION NECESSARY

  Patient problems: Bone Fracture(s)

  MAUDE report 11967106 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2013; DATE OF REVISION: (B)(6) 2021; (RIGHT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity

  MAUDE report 11818708 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE REVISION. ATTUNE PRIMARY REVISED FOR MID FLEXION INSTABILITY. IMPLANTS WERE ABSOLUTELY SOLID AND NO PROBLEM REGARDING THE IMPLANTS AT ALL.

  Patient problems: Joint Laxity

  MAUDE report 11561504 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SEPTIC KNEE: INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION SURGERY.

  Patient problems: Edema; Injury; No Code Available; Pain; Unspecified Infection

  MAUDE report 10872341 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT KNEE ATTUNE REVISION TO TREAT PAIN, SCAR TISSUE, WALKING DIFFICULTY, FLEXION CONTRACTURE, AND JOINT INSTABILITY. UPON ENTERING THE JOINT, THE SURGEON DETERMINED THAT THE FLEXION CONTRACTURE WAS DUE TO ABUNDANT SCAR TISSUE ADHERING TO THE QUADRICEPS TENDON, WHICH REQUIRED A QUADRICEPS PLASTY TO REPAIR. ABUNDANT SCAR TISSUE AND SYNOVITIS WAS DEBRIDED FROM THE PERIARTICULAR SPACE. THE SURGEON IDENTIFIED SIGNIFICANT WEAR DEBRIS THROUGHOUT THE JOINT. THE TIBIAL TRAY WAS GROSSLY LOOSE AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. THERE WAS A SIGNIFICANT TIBIAL BONE EROSION. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. ONCE REMOVED, THE SURGEON IDENTIFIED DISTAL FEMORAL STRESS SHIELDING, OSTEOPENIA, AND CONDYLE BONE EROSION. THE BONE DEFECTS IN THE TIBIA AND FEMUR REQUIRED RECONSTRUCTION WITH A STEM AND CONE. THE PATELLA WAS WELL-FIXED, WITHOUT WEAR, AND RETAINED. THE TIBIAL INSERT WAS REVISED. THE PATIENT WAS REVISED WITH A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTED THAT THE PATIENT¿S OBESITY WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE ATTUNE KNEE. DOI: (B)(6) 2015. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; No Code Available; Pain; Pocket Erosion; Synovitis

  MAUDE report 10489860 ↗
• MalfunctionMar 5, 2020Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  (B)(6) 2017: PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT WITH DEPUY IMPLANTS AND DEPUY CEMENT. (B)(6) 2019: WORKER'S COMPENSATION FORM INDICATES THE PATIENT REPORTS PAIN, SWELLING, AND POPPING/GRINDING. THE PATIENT CURRENT AMBULATES WITH A 4 WHEEL WALKER AND LIKELY HAS ASPECTIC LOOSENING. DOI: (B)(6) 2017. DOR: NO REVISION (RIGHT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9794736 ↗