ATTUNE 1504-00-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295041146), received between Oct 19, 2017 and Jun 4, 2026 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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.

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

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A COMPLETE REVISION TODAY FOR ARTHROFIBROSIS. PATIENT SLOWLY LOST MOBILITY UNTIL KNEE WAS VERY STIFF. DURING REMOVAL OF THE TIBIAL COMPONENT IT WAS NOTED THAT THERE WAS CEMENT DEBONDING BETWEEN THE IMPLANT AND THE CEMENT. THIS WAS THE FIRST GENERATION ATTUNE TIBIAL COMPONENT. NO SURGICAL DELAY. REVISION WAS PERFORMED WITHOUT ISSUE. NOTHING ELSE TO REPORT. IT WAS STATED THAT TIBIAL COMPONENT WAS 1ST GEN ATTUNE TIBIAL BASEPLATE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. COMPETITOR CEMENT WAS USED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 25393859 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. THERE WAS KNEE REMOVAL AND IMPLANTATION OF NEW IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25127656 ↗
• MalfunctionMar 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR PROSTHESIS LOOSENING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2015, DATE OF EVENT: UNK JAN 2023, (LEFT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION AND OBSERVATION.

  Patient problems: Insufficient Information

  MAUDE report 18959177 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18465467 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS; CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023; DATE OF EVENT: 20 SEP 2023; (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 18455955 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN; DOR: UNKNOWN; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18184413 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT HAD A LEFT KNEE ARTHROSCOPY WITH 3 COMPARTMENT SYNOVECTOMY AND DEBRIDEMENT, MANIPULATION UNDER ANESTHESIA FOR THE LEFT KNEE TO ADDRESS ARTHROFIBROSIS OF THE LEFT KNEE. THERE WERE NO COMPONENTS REVISED. DOI: (B)(6) 2017. DOE: (B)(6) 2018. AFFECTED SIDE: LEFT KNEE. THIS IS A LINK OF (B)(4).

  Patient problems: Adhesion(s)

  MAUDE report 16843228 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY END-STAGE VALGUS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA, AND DEPUY CEMENT X1 WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2022, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TO ADDRESS FAILED LEFT TOTAL KNEE, ARTHROFIBROSIS, LIMITED RANGE OF MOTION, AND ASEPTIC LOOSENING OF THE TIBIAL TRAY. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY HAD DEBONDED FROM THE CEMENT. THE FEMORAL COMPONENT AND INSERT WERE REVISED WITH NO ALLEGATION OF DEFICIENCY. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI:(B)(6) 2017 DOR:(B)(6) 2022 (LEFT KNEE). THIS IS A LINK OF (B)(4).

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 16831067 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS POOR RANGE OF MOTION AND THINNEST AVAILABLE INSERT SO AND REVISION KNEE IS PERFORMED. NO PATIENT HARM OCCURS. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2021. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 16452929 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN AND INSTABILITY. EXPLANTED THE FEMUR AND TIBIAL INSERT AND TIBIAL TRAY. IMPLANT AN ATTUNE CRS FEMUR WITH AN AUGMENT AND PRESSFIT STEM, RP REVISION TRAY WITH CEMENTED STEM AND 14MM CRS RP INSERT. THIS WAS THE PATIENT'S LEFT KNEE. THERE WAS NO DELAY IN SURGERY OR INJURY TO THE PATIENT. ORIGINAL DOS (B)(6) 2018 AT THE SAME HOSPITAL. DOI: (B)(6) 2018, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15892966 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLOOD CLOT LEFT LUNG (PULMONARY EMBOLISM). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: TREATED WITH LOVENOX AND PRESCRIBED XARELTO.

  Patient problems: Pulmonary Embolism

  MAUDE report 15872653 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO-DOTS. SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS, STIFFNESS, AND DIFFICULTY PROGRESSING WITH ROM. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 15443174 ↗
• MalfunctionSep 12, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN PREPARING FOR IMPLANTATION, UPON OPENING THE STERILE PACKAGING OF THE FEMUR. THERE WAS A FOREIGN OBJECT ON THE BACK OF THE IMPLANT. WE IMMEDIATELY OPENED A NEW IMPLANT FOR THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401814 ↗
• InjuryFeb 16, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT FELT A DEVELOPED A CLICKING NOISE IN HER KNEE AND A LOOSING OF HER SOFT TISSUES TO THE POINT IT FELT UNSTABLE TO HER. A FULL REVISION WAS COMPLETED. NONE OF THE COMPONENTS WERE LOOSE. THE PATELLA WAS LEFT INTACT. THE END RESULT WAS THE PATIENT HAD A FULL RANGE OF MOTION FROM FLEXION TO EXTENSION. NO FURTHER INFORMATION IS AVAILABLE ABOUT THIS CASE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Fall; Joint Laxity

  MAUDE report 13542643 ↗
• InjuryDec 8, 2021Use of Device Problem; Use of Device Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE TIBIAL TRAY AND FEMORAL COMPONENT WERE BOTH MALPOSITIONED IN SIGNIFICANT VARUS. FIBROUS TISSUE AND OSTEOLYSIS WERE DEBRIDED EXTENSIVELY. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12960214 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COMPONENTS WERE REVISED DUE TO LIMITED RANGE OF MOTION. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12852059 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE PRIMARY KNEE REPLACEMENT ON THE (B)(6) 2019 FOR PROGRESSIVE OA FOLLOWING A MOTORCYCLE ACCIDENT APPROXIMATELY 18 YEARS PRIOR TO THE PRIMARY TKR. THIS PATIENT ALSO UNDERWENT MULTIPLE OTHER SURGERIES ON THE SAME KNEE PRIOR TO THE PRIMARY TKR INCLUDING A LIGAMENT STABILIZATION AND HTO. SHE HAS NEVER SETTLED FOLLOWING HER ATTUNE TKR, SO WAS REVISED FOR PAIN AND STIFFNESS BEING LISTED AS THE CAUSE OF REVISION.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 12331759 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GROSS INSTABILITY DUE TO EXTENSOR MECHANISM DISRUPTION. PATELLA WAS RETAINED. NO LOOSENING REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 11916290 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED PRIMARY BILATERAL ATTUNE TKAS TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND AN UNKNOWN NUMBER OF DEPUY CEMENTS WERE USED ON EACH KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, SCAR TISSUE WAS DEBRIDED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11665391 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 25 NOV 2020 WAS REVIEWED. ON (B)(6) 2016, THE PATIENT HAD A LEFT KNEE ARTHROPLASTY TO ADDRESS SEVERE DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT. ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY, FEMORAL AND TIBIAL IMPLANTS, TO ADDRESS FAILED LEFT TOTAL KNEE, INSTABILITY, AND ASEPTIC LOOSENING. DURING THE PROCEDURE THE SURGEON OBSERVED DIFFUSE HYPERTROPHIC SYNOVITIS. THERE WAS GROSS LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY COMPONENT AT THE BONE TO CEMENT INTERFACE FOR BOTH. THE PATELLA WAS LEFT IN-SITU. COMPETITOR COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2016. DOR: (B)(6) 2020 (LEFT KNEE).

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 11055997 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT A FLEXION CONTRACTURE OF 5 DEGREES. UPON ENTERING THE JOINT, THE SURGEON EVACUATED A SMALL EFFUSION AND DEBRIDED PERIARTICULAR SYNOVITIS. THE TIBIAL TRAY WAS GROSSLY LOOSE AND EASILY REMOVED. THE SURGEON EXCISED CYSTIC LESION FROM THE UNDERLYING TIBIAL BONE. THE FEMORAL COMPONENT WAS WELL FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL FIXED AND RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOE: (B)(6) 2014; (MUA, NO REVISION, CAPTURED IN (B)(4)). DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10785890 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 06 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. ATTUNE KNEE COMPONENTS, AND SMARTSET CEMENT X 2 WERE IMPLANTED IN THE PROCEDURE. ON (B)(6) 2014, THE PATIENT UNDERWENT A LEFT KNEE REVISION. THERE WERE NO OPERATIVE NOTES PROVIDED WITH THE MEDICAL RECORDS. DOI: (B)(6) 2014 DOR: (B)(6) 2014 (LT KNEE).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10778919 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR ARTHROFIBROSIS AND ASEPTIC LOOSENING OF TIBIA COMPONENT. PATIENT WAS REVISED ON (B)(6) 2020. CEMENT MANUFACTURER UNKNOWN. ORIGINAL IMPLANT DATE (B)(6) 2017.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10480172 ↗
• InjuryJun 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RECEIVED A LEFT PRIMARY FIXED-BACK ATTUNE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 1 WAS UTILIZED. UPON ENTERING THE JOINT, THE SURGEON DETERMINED THAT THE PATIENT HAD EXTENSIVE TRICOMPARTMENTAL ARTICULAR CARTILAGE LOSS, POOR SOFT TISSUE, AND FAIR BONE STOCK. THE SURGEON NOTES THAT SOFT TISSUE BALANCING WAS DIFFICULT DUE TO THE PATIENT¿S VALGUS AND TIGHT LATERAL STRUCTURES AND LAXITY EVERYWHERE ELSE. THE TIBIAL AND FEMORAL COMPONENTS WERE IMPLANTED IN SLIGHT EXTERNAL ROTATION TO IMPROVE PATELLAR TRACKING. EXTENSIVE RELEASE OF THE POPLITEUS AND COLLATERAL AND IT BAND PERFORMED TO CORRECT THE VALGUS DEFORMITY AND BALANCE GAPS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT REPORTED TO THE ER 4 DAYS POSTOPERATIVELY WITH PAIN AND INABILITY TO BEAR WEIGHT DUE TO DISLOCATION OF THE LEFT KNEE. THE KNEE WAS REDUCED AND PLACED IN A BRACE. THE PATIENT EXPERIENCED A SECOND DISLOCATION A FEW DAYS LATER AND THE SURGEON DETERMINED THERE WAS TOO MUCH JOINT LAXITY AND RECOMMENDED REVISION OF THE LEFT KNEE. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, WALKING DIFFICULTY, AND RECURRENT DISLOCATIONS SECONDARY TO JOINT LAXITY. UPON ENTERING THE

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; No Code Available; Pain

  MAUDE report 10207224 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2016. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10162886 ↗