ATTUNE 1504-10-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295041740), received between Aug 16, 2017 and Feb 13, 2025 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS DEBRIS FOUND ON THE FEMORAL COMPONENT OF THE IMPLANT. ANOTHER IMPLANT WAS OPENED AND THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376344 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION FOR PAIN AND SUSPICIOUS SPECT-CT. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL.

  Patient problems: Pain

  MAUDE report 21366705 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. THE SURGEON DECIDED TO REVISE THE KNEE. THE FEMORAL AND TIBIAL COMPONENTS SHOWED NO SIGNS OF LOOSENING. THE POLY WAS EXTRACTED AND EXHIBITED MINOR SIGNS OF WEAR AROUND THE BASE AND POST. THE PATELLA REMAINED IN PLACE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20087437 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PROSTHETIC FRACTURE. IT WAS REVISED TO A LPS DFR. THE CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16380451 ↗
• MalfunctionJan 4, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INNER PACKAGING DEFORMED. IT WAS REPORTED THAT DURING THE SURGERY, OPENED THE OUT-BOX, NOTED THE INNER PACKAGING WAS DEFORMED (AS THE PHOTO SHOWS). ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095040 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. CEMENT MANUFACTURER WAS NOT INDICATED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15122190 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION RIGHT TOTAL KNEE ARTHROPLASTY.

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

  MAUDE report 12542132 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. SURGEON THOUGHT IT WAS FROM A LOOSE TIBIA. UPON REMOVAL OF THE TIBIA IT APPEARED TO BE WELL FIXED. SURGEON JUST REVISED THE TIBIAL SIDE TO AN ATTUNE REVISION RP BASEPLATE WITH A SLEEVE AND STEM. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12196279 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY RIGHT ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTED THE PROCEDURE WAS COMPLEX DUE TO THE PATIENT¿S OBESITY. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, STIFFNESS, AND ARTHROFIBROSIS. UPON ENTERING THE JOINT, ABUNDANT SCAR TISSUE WAS DEBRIDED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A DEPUY TC3/MBT REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Pain

  MAUDE report 11726846 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UPON ENTERING THE JOINT, SCAR TISSUE WAS ENCOUNTERED AND REMOVED. ALL IMPLANTS WITH THE EXCEPTION OF THE PATELLA WERE REVISED. THE SURGERY WAS COMPLETED. DOI: (B)(6) 2016. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11148278 ↗
• InjuryAug 26, 2020Malposition of Device; Malposition of Device

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A BILATERAL TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED BILATERALLY, AND COMPETITOR CEMENT WAS UTILIZED X2 BILATERALLY FOR A TOTAL QUANTITY OF 4. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, FAILED RIGHT KNEE REPLACEMENT WITH GROSS LOOSENING AND VARUS COLLAPSE OF THE TIBIA, OSTEOLYSIS AND MALALIGNMENT OF THE FEMORAL AND PATELLA COMPONENTS. UPON ENTERING THE JOINT, PARAPATELLAR ADHESIONS WERE RELEASED AND SYNOVECTOMY WAS PERFORMED. THE TIBIAL COMPONENT WAS EASILY REMOVED, LOOSENING NOTED AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR IMPLANTS WERE UTILIZED AT THIS REVISION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Osteolysis; Pain

  MAUDE report 10454745 ↗
• InjuryJul 22, 2020Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS REVISED TO ADDRESS DISTAL FEMORAL PERI-PROSTHETIC FRACTURE DUE TO A FALL AND LOOSENING OF THE FEMORAL COMPONENT AT AN UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10309294 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TIGHTNESS IN BOTH FLEXION AND EXTENSION. THE PRIMARY ATTUNE FEMORAL COMPONENT WAS REMOVED, SO THAT A POSTERIOR CAPSULE RELEASE COULD BE PERFORMED. HER MEDIAL COLATERAL LIGAMENT WAS ALSO RELEASED OR LENGTHEN SLIGHTLY. A REPLACEMENT ATTUNE PS FEMUR OF THE SAME SIZE AND A REPLACEMENT ATTUNE RP PS TIBIAL INSERT WAS IMPLANTED. THE PRIMARY RP TIBIAL BASE (TRAY) WAS NOT REVISED. THERE WAS NO SUGGESTION BY ANYONE THAT THERE WAS OR MAY BE DEFICIENCIES WITH THE PRODUCTS. NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10257358 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC NOTE DATED 12 DEC 2019: PATIENT PRESENTS WITH PERSISTENT PAIN AND INSTABILITY. PHYSICAL EXAM CONFIRMS THE INSTABILITY. X-RAYS INDICATE POSSIBLE LOOSENING OF THE TIBIAL TRAY. THE PHYSICIAN NOTES THE LOOSENING OF THE TRAY WAS NOT CONFIRMED. PATIENT IS REFERRED FOR REVISION SURGERY.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 10235715 ↗
• InjuryMay 26, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT ADVANCED END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A REVISION OF THE RIGHT KNEE TO TREAT PAIN AND SUSPECTED LOOSENING. THE FEMORAL COMPONENT AND TIBIAL TRAY HAD MINIMAL LOOSENING BUT WERE REVISED DUE TO UNSPECIFIED ¿SOFT TISSUE APPEARANCE¿. THE LOOSENING INTERFACE WAS UNKNOWN. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED DEPUY TC3 REVISION PRODUCTS UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10087705 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY. THE PREVIOUSLY UNRESURFACED PATELLA WAS RESURFACED DURING THE OPERATION. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. ALL PRODUCTS WERE REVISED. DOI: (B)(6) 2014; DOR: (B)(6) 2015 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9582297 ↗
• InjuryJan 9, 2020Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  MEDICAL RECORDS RECEIVED AD 09 DEC 2019. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO PATELLOFEMORAL ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SUBSIDENCE, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS GROSSLY LOOSE FROM THE CEMENT AND WELL-FIXED TO THE TIBIA. HE INDICATED THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND REMOVED. THE SURGEON INDICATED THE PATELLA WAS WELL-FIXED AND RETAINED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY CEMENT X 2.

  Patient problems: No Code Available; Pain

  MAUDE report 9570854 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS FALLEN AND HAD A SMALL FX IN HER MEDIAL CONDYLE. KNEE WAS UNSTABLE THROUGH OUT RANGE OF MOTION. WE UPSIZED THE FEMUR TO A 4 AND IMPLANTED A VARUS/VALGUS CONSTRAINED INSERT. COMPONENTS WERE NOT LOOSE. THIS IS ALL THE INFORMATION I HAVE ON THIS CASE. DOI: (B)(6) 2018. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9520102 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: MEDICAL RECORDS RECEIVED ON AD 27 FEB 2020 WERE REVIEWED ON AD 12 MARCH 2020. PRIMARY OPERATIVE NOTES INDICATE THE PATIENT RECEIVED A PRIMARY ATTUNE TKA TO TREAT SEVERE OSTEOARTHRITIS OF THE RIGHT KNEE. INTRAOPERATIVELY, THE SURGEON NOTED SEVERE DEGENERATIVE CHANGES OF THE NATURAL JOINT AND EFFUSION. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Code Available; Pain

  MAUDE report 9347553 ↗
• InjuryNov 14, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO STIFFNESS, INSTABILITY, AND PAIN. DOI: (B)(6) 2016. DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: Joint Disorder; Pain

  MAUDE report 9322308 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, STIFFNESS, ARTHROFIBROSIS, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017, DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9312301 ↗
• InjuryNov 7, 2019Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION, IRRIGATION AND DEBRIDEMENT, AND REMOVAL OF COMPONENTS AND PLACEMENT OF ANTIBIOTIC SPACERS DUE TO PAIN. THE SURGEON NOTED A THICKENED, GRAYISH SYNOVIAL TISSUE AND BRACKISH-APPEARING FLUID. THE FLUID WAS SENT FOR CULTURE WITH NO RESULT GIVEN IN THE MEDICAL RECORDS. THE TIBIAL TRAY WAS SUBSIDED AND LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIA APPEARED TO BE NECROTIC AND THE NECROTIC BONE WAS REMOVED FROM THE AREA. THE FEMORAL COMPONENT WAS LOOSE AT AN UNKNOWN INTERFACE. ALL COMPONENTS WERE REMOVED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2016; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9291898 ↗
• InjuryAug 23, 2019Loss of or Failure to Bond; Use of Device Problem; Malposition of Device; Loss of or Failure to Bond; Use of Device Problem; Malposition of Device

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN AND NICKEL ALLERGY. THE TIBIAL TRAY WAS SUBSIDED, MALPOSITIONED, AND LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS MALPOSITIONED AND LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED SCARRING AND SYNOVITIS. THE SURGEON REPORTED EROSIVE CYSTIC CHANGE ON BOTH THE FEMUR AND TIBIA. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Cyst(s); Hypersensitivity/Allergic reaction; No Code Available; Pain; Scarring

  MAUDE report 8927954 ↗
• InjuryAug 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 13 SEP 2018. RECORDS INDICATE PATIENT RECEIVED AN ATTUNE TKA. NO ALLEGATIONS PROVIDED OF PATIENT INJURY OR PRODUCT FAILURE, NOR REPORT OF REVISION. DOI: (B)(6) 2016, DOR: UNKNOWN (RIGHT).

  Patient problems: Adhesion(s); Joint Disorder; Loss of Range of Motion; Muscular Rigidity; No Code Available; Pain

  MAUDE report 8887738 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PARTIAL MOTOR WEAKNESS OF RIGHT ANKLE DORSIFLEXORS ASSOCIATED WITH CORRECTION OF VALGUS DEFORMITY AND A PRESUMED COMMON PERONEAL NERVE PALSY. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction; No Code Available; Weakness

  MAUDE report 8029108 ↗