ATTUNE 1504-00-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10603295041214), received between May 16, 2018 and May 12, 2026 — classified as 58 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED RIGHT TOTAL KNEE WITH ANTIBIOTIC SPACER. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25147926 ↗
• InjuryNov 14, 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 INSTABILITY WITH DISLOCATED AND SPUN-OUT ROTATING PLATFORM LINER, IRREDUCIBLE. SIGNIFICANT INTRAOPERATIVE INBALANCE IDENTIFIED WITH POSTEROLATERAL INSTABILITY REQUIRING COMPLETE REVISION. PATELLAR COMPONENT RETAINED. DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: PROBABLE PROCEDURE RELATED: PROBABLE DATE OF EVENT: (B)(6) 2025 DATE OF IMPLANT: (B)(6) 2025 DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: RIGHT TREATMENT/IMPACT: NONE/OBSERVATION: YES, COMPONENTS REMOVED: FEMORAL: YES TIBIA: YES AND INSERT: YES.

  Patient problems: Joint Laxity

  MAUDE report 23555141 ↗
• InjuryApr 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF BOTH HIS PRIMARY FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DURING THE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THERE WAS NO CEMENT REMAINING ON THE EXPLANTED COMPONENTS. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21925819 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 10 APR 2019 . DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: : CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 20471361 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2024, PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS CHRONIC DEEP INFECTION, SECONDARY TO A FALL IN (B)(6) 2023, THAT RESULTED IN WOUND DEHISCENCE (TREATED AT THAT TIME WITH SURGICAL IRRIGATION & DEBRIDEMENT AND IV ANTIBIOTICS--SEE (B)(4)), AND THEN SUBSEQUENTLY LED TO THE PATIENT'S CURRENT PAIN, SWELLING, AND LIMITED RANGE OF MOTION AT THE TIME OF THIS REVISION. ON THE DAY OF SURGERY, PATIENT PRESENTED WITH A LARGE BOIL (INFECTED CYST) AND POOR SKIN INTEGRITY AT THE PREVIOUS SURGICAL; SITE. SURGEON PERFORMED AN EXTENSIVE SYNOVECTOMY TO REMOVE INFECTED SOFT TISSUE. ALL TOTAL KNEE IMPLANTS WERE EXPLANTED (THEY WERE WELL FIXED), AND AN ANTIBIOTIC IMPREGNATED SPACER CONSTRUCT WAS IMPLANTED TO TREAT THE INFECTION. THERE WERE NO COMPLICATIONS--PATIENT TOLERATED THE SURGERY WELL.

  Patient problems: Cyst(s); Erythema; Fall; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 19863257 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 5 JUN 2024. ON (B)(6) 2017, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT AND PATELLA. ON (B)(6) 2023, THE PATIENT HAD A RIGHT TOTAL KNEE REVISION TO ADDRESS ASEPTIC LOOSENING OF THE RIGHT TOTAL KNEE AND FEMORAL OSTEOLYSIS. PRIOR TO SURGERY, THE PATIENT WAS REPORTED TO HAVE HAD PAIN, DECREASE RANGE OF MOTION, STIFFNESS, FIBROSIS, DECLINING FUNCTION. DURING THE PROCEDURE, THE SURGEON REPORTED FINDING OSTEOLYSIS OF THE FEMUR AND NO CEMENT ADHERED TO BACK OF THE TIBIAL TRAY. (LOOSENING) OSTEOPHYTES WERE REMOVED FROM THE PATELLA. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING COMPETITOR CEMENT. UPDATE AD 5 JUN2024: UPDATE EVENT DESCRIPTION: ON (B)(6) 2017, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT AND PATELLA. (B)(6) 2022 MEDICAL RECORDS NOTE RIGHT KNEE PAIN AND DYSFUNCTION AFTER TKA, AS WELL AS LEFT KNEE PAIN (NO IMPLANT) RIGHT KNEE PAIN, SWELLING, DECREASE RANGE OF MOTION, STIFFNESS. PATIENT HAD A PREVIOUS INJECTION

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Osteolysis; Pain

  MAUDE report 19567963 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA PLATEAU ENFORCEMENT PERFORMED DUE TO PAIN.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19491407 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A KNEE SPACER IN AND WAS STILL INFECTED SO PRODUCTS WERE REMOVED AND NEW SPACER WAS PUT BACK IN. DOI: (B)(6), 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19486770 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED RTK. SURGEON WENT IN AND REMOVED ALL 4 TOTAL KNEE COMPONENTS; FEMORAL, TIBIAL, INSERT AND PATELLA COMPONENTS. AFTER AN EXTENSIVE IRRIGATION AND DEBRIDENT, SURGEON CHOOSE TO PUT IN A TEMPORARY HI DOSE ANTIBIOTIC SPACER. THE SPACER COMPONENTS CONSISTED OF AN ATTUNE CR CEMENTED FEM COMPONENT RIGHT AND AN ATTUNE ALL POLY TIBIAL COMPONENT. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19219952 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REMOVAL OF TOTAL KNEE FOR SEPSIS, IMPLANT ANTIBIOTIC SPACER. DOI- UNKNOWN; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19079864 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 18443806 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED KNEE REVISION SURGERY. THIS WAS DUE TO FAILURE OF PRIMARY ATTUNE IMPLANTS IN SITU. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18383210 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS A SURGICAL DELAY ABOUT 1 HOUR. SURGEON IMPLANTED 3-4 SMALL FRAGMENTS SCREWS.

  Patient problems: Limb Fracture

  MAUDE report 18360245 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS EXPLANTED FOR INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022; DOR- (B)(6) 2023; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18140831 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED AND IMPLANTS WERE EXPLANTED. ARTICULATING SPACER WAS PUT IN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18020402 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED REVISION OF ATTUNE TKA IMPLANTS. PATIENT HAD RECEIVED PRIMARY IMPLANTS (B)(6) 2020. SOON AFTER COMPLAINED OF PAIN. PAIN GOT PROGRESSIVELY WORSE OVER TIME. HEAT SIGNATURE SCANS REVEALED POTENTIAL PATELLA LOOSENING BUT NOT CONCLUSIVE. ALL CULTURE FOR INFECTION WERE NEGATIVE. DUE TO INCREASING PAIN AND POTENTIAL HEAT SIGNATURE, DECISION WAS MADE TO REVISE THE JOINT REPLACEMENT USING ATTUNE REVISION. DOI: (B)(6) 2020. DOE: (B)(6), 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17642665 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 16 MAY 2023.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17097398 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 PATIENT HAS RIGHT KNEE PAIN, GAIT INSTABILITY, JOINT SWELLING, LIMPING, WEAKNESS, AND KNEE GIVING AWAY. SHE WAS TREATED WITH PHYSICAL THERAPY, NSAIDS, ALEVE AND DRY NEEDLING. IT WAS NOTED THE PATIENT HAD RECEIVED LUMBAR EPIDURAL INJECTIONS DUE TO LUMBAR SPONDYLOLISTHESIS, DISC DEGENERATION, AND IDIOPATHIC SCOLLOSIS LUMBAR REGION.

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17096938 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS. 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) 2021, (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s)

  MAUDE report 16088176 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS INDICATE A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING ATTUNE IMPLANTS. THE PATELLA WAS RESURFACED AND SMARTSET GMV CEMENT WAS USED. PATIENT WAS LATER REVISED FOR GLOBAL INSTABILITY AND TIBIAL COMPONENT MALALIGNMENT. WHILE THE SURGEON STATES THE TIBIAL COMPONENT WAS EASY TO REMOVE, HE STATES THE FEMORAL, PATELLA, AND TIBIAL TRAY WERE ALL WELL-FIXED. THE FEMORAL COMPONENT, INSERT, AND TRAY WERE REVISED. DOI: (B)(6) 2015, DOR: (B)(6) 2022 (RIGHT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 15969937 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017: PATIENT RECEIVED A RIGHT KNEE ATTUNE TKA TO TREAT CHONDROMALACIA TYPE II/III AND END-STAGE DJD AFTER FAILED ATTEMPTS TO MANAGE THE SYMPTOMS. THE PATIENT HAD A SKIING ACCIDENT SEVERAL YEARS EARLIER WHERE THE ACL WAS TORN AND HAS REQUIRED INJECTIONS AND ARTHROSCOPIC SURGERIES, WHICH UNSUCCESSFULLY TREATED THE PAIN AND DEGENERATION OF THE KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2018 PATIENT HAD RIGHT KNEE MANIPULATION UNDER ANESTHESIA WITH AN INTRAARTICULAR STEROID INJECTION TO TREAT PAIN, STIFFNESS AND REDUCED ROM SECONDARY TO ARTHROFIBROSIS. DOE: (B)(6) 2018; RIGHT KNEE SECOND COMPLAINT.

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

  MAUDE report 15851634 ↗
• InjuryNov 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ATTUNE LITIGATION RECORDS RECEIVED. PATIENT WAS REVISED WAS DUE TO PAIN AS A RESULT OF MECHANICAL LOOSENING, UNKNOWN INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 15844275 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2013 WITH DEPUY SYNTHES IMPLANTS INCLUDING A RESURFACED PATELLA. CEMENT WAS COMPETITOR. PATIENT THEN HAD PAIN AND INSTABILITY REQUIRING A RIGHT REVISION SURGERY ON (B)(6) 2022. INTRAOPERATIVE FINDINGS WERE A LOOSE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2013. DOR: (B)(6) 2022 (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain

  MAUDE report 15840549 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES PERSISTENT PAIN, DISCOMFORT, SWELLING, INSTABILITY, DIFFICULTY AMBULATING, SWELLING, WALKING WITH A LIMP AND LIMITED RANGE OF MOTION. SCAN SHOWED MODERATE DIFFUSE UPTAKE ABOUT THE RIGHT TKA. BONE SCAN REPORTED OSTEOLYSIS AND HARDWARE LOOSENING. DURING REVISION ALLEGES BY THE SURGEON OBSERVED THE TIBIAL BASE COME FREE FROM THE TIBIA WITH LITTLE FORCE. CEMENT DID NOT BOND OR ADHERE TO THE TIBIAL BASE. FAILURE OF THE CEMENT BONDING TO THE TIBIAL BASE CAUSED ASEPTIC OR MECHANICAL LOOSENING. DOI: (B)(6) 2016. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fatigue; Inflammation; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 15111492 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 14171826 ↗