ATTUNE 1504-10-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295041665), received between Aug 6, 2019 and Mar 4, 2026 — classified as 27 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN AND ARTHROFIBROSIS. NO LOOSENING OF IMPLANTS AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24513746 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SEPTIC MOBILIZATION OF RIGHT KNEE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22204553 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS POOR PATELLAR TRACKING POST TKA. ALSO HAD A POLY EXCHANGE AND PATELLA REPAIR ON (B)(6) 2023. ALIGNMENT AND COMPONENT SIZING APPEARS APPROPRIATE VIA X-RAY. OPERATIVELY, IT IS NOTED THAT THE PATIENT'S LEG DOES LIE IN INTERNAL ROTATION, WHICH MAY BE FROM THE HIP, AS THIS IS ALSO APPARENT ONCE ALL COMPONENTS ARE REMOVED A LATERAL RELEASE WAS PERFORMED AND THIS DID NOT RESOLVE THE ISSUE, SO THE SURGEON DECIDED TO PERFORM A FULL REVISION DUE TO CONTINUED PATELLAR MAL-TRACKING. NO DELAY NOR PATIENT HARM WAS NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENTS. PATELLAR COMPONENT WAS WELL FIXED AND LEFT IN PLACE. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22170835 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT KNEE REVISION AND PLACEMENT OF SPACER DUE TO INFECTION. NO OTHER INFORMATION KNOWN. DOI: APRIL 3, 2023. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17747514 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17140528 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMUR AND TIBIA WHERE REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16478032 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED SO THE SURGEON DECIDED TO REMOVE THEIR IMPLANTS AND PUT IN A CEMENT SPACER. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15561457 ↗
• InjuryAug 23, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT ATTUNE PRIMARY KNEE TO TREAT END-STAGE DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT ASEPTIC LOOSENING. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY. THE FEMORAL COMPONENT WAS LOOSENED AT AN UNKNOWN INTERFACE AND REVISED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS SIGNIFICANT MEDIAL TIBIAL BONE LOSS REQUIRING A COMPETITOR REVISION CONE AND SCREWS TO RECONSTRUCT THE TIBIA. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION KNEE CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15275566 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVED AN ATTUNE TKA DUE TO INFECTION. DOI: UNK. DOR: UNK. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15249704 ↗
• InjuryMay 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(4) MEDICAL RECORDS AD 26 APR 2022 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A LEFT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS LOOSE TOTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE THE SURGEON REPORTED FINDING LOOSE FEMORAL COMPONENT WITH SIGNIFICANT LATERAL FEMORAL CONDYLAR BONE LOSS AS WELL AS GROSSLY LOOSE TIBIAL COMPONENT. THERE WAS FIBRINOUS TISSUE WITH SIGNIFICANT BONE LOSS AROUND THE FEMORAL COMPONENT. THE TIBIAL TRAY WAS NOTED TO BE GROSSLY LOOSE AT THE CEMENT/IMPLANT INTERFACE. THE INSERT WAS REMOVED WITHOUT ALLEGATION OF DEFICIENCY. DEPUY COMPONENTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT X2. DOI: (B)(6) 2014; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Adhesion(s); Unspecified Tissue Injury

  MAUDE report 14414858 ↗
• InjuryApr 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED PRIMARY ATTUNE TKAS TO TREAT END-STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, FEMORAL OSTEOLYSIS WAS IDENTIFIED. THE FEMORAL COMPONENT WAS LOOSENED AT AN UNKNOWN INTERFACE AND 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 LOOSENED PATELLA ¿JUST FELL OFF¿ AND WAS REVISED. THE LOOSENED INTERFACE OF THE PATELLAR BUTTON WAS NOT PROVIDED. 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: Osteolysis; Pain

  MAUDE report 11673289 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS NOTED TO BE SCAR REMOVAL. THE SURGEON ALSO NOTED MINIMAL BONE LOSS WITH REMOVAL OF THE WELL-FIXED FEMORAL COMPONENT. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2020 ;LEFT KNEE.

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

  MAUDE report 11463582 ↗
• InjuryMar 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMUR WAS LOOSE AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. REVISION NECESSARY. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11392137 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO COMPLAINING OF LATERAL PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11293642 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY ON (B)(6) RIGHT AFTER COVID OUTBREAK HAPPENED. DUE TO ALL THE UNKNOWNS, HE WAS UNABLE TO RECEIVE THERAPY POST-OPERATIVELY. HIS KNEE HAD TO BE REVISED DUE TO SIGNIFICANT SCARRING. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10455081 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY LEFT ATTUNE AND TO TREAT PAIN SECONDARY TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 3 WAS UTILIZED. THERE SURGEON NOTES THERE WAS SEVERE TRICOMPARTMENTAL ARTICULAR CARTILAGE LOSS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT TIBIAL PAIN AND WALKING DIFFICULTY SECONDARY TO ACUTE AND CHRONIC INFLAMMATION. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SIGNIFICANT GREY TINGED PSEUDO SYNOVIUM, SYNOVITIS, AND DENSE FIBROSIS. PATHOLOGY OF THE EXCISED SYNOVIUM IDENTIFIED ACUTE AND CHRONIC INFLAMMATORY MARKERS INDICATING HYPERSENSITIVITY AND FOREIGN BODY REACTION. PATHOLOGY REPORTS DID NOT CONFIRM THE PRESENCE OF INFECTION. THE SURGEON DECIDED TO REVISE ALL COMPONENTS TO A DEPUY ANTIBIOTIC SPACER. THERE WERE NO REPORTED PRODUCT DEFECTS FOR THE PATELLA, FEMORAL COMPONENT, TIBIAL TRAY, OR TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain; Synovitis

  MAUDE report 10234234 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. FEMUR, INSERT AND TIBIAL WERE ALL REMOVED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10165085 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE CLAIM RECORD RECEIVED. CLAIM RECORD ALLEGES INJURIES, PAIN, ANGUISH, DISFIGUREMENT AND PHYSICAL IMPAIRMENT. DOI: (B)(6) 2016. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Deformity/ Disfigurement; Injury; No Code Available; Pain

  MAUDE report 10104174 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL BASE AT UNKNOWN INTERFACE. THE CEMENT IS DEPUY CEMENT.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9505681 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE AND VALGUS. 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) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, LACK OF MOTION, FUSIONS, AND PAIN. THE SURGEON REPORTED THE TIBIA HAD BONE THAT HAD GROWN UP AROUND THE TIBIAL TRAY AS IF THE BODY WAS TRYING TO STABILIZE A LOOSE IMPLANT. THE TIBIAL TRAY WAS EASILY REMOVED AND HAD NO CEMENT ADHERENT AT THE TRAY TO CEMENT INTERFACE. THE CEMENT WAS WELL-FIXED TO THE BONE. THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. THE SURGEON INDICATED THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY REVISION KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2019, (LT KNEE).

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

  MAUDE report 9496786 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN. THE SURGEON REPORTED THE PATELLA WAS WELL-FIXED, HAD NO WEAR, AND WAS RETAINED. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH OSTEOTOMES, ALSO WITH NO SIGNIFICANT BONE LOSS. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS REMOVED WITH FLEXIBLE OSTEOTOMES AND NO SIGNIFICANT BONE LOSS. THE PATIENT WAS IMPLANTED WITH COMPETITOR COMPONENTS AND COMPETITOR BONE CEMENT. THERE WERE NOT SURGICAL COMPLICATIONS REPORTED. DOI: (B)(6) 2014; DOR: (B)(6) 2015; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9490484 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS FROM COMPETITOR. THE TIBIAL COMPONENT, FEMORAL COMPONENT AND THE PATELLA WERE REMOVED. THERE WAS NO BONE CEMENT PRESENT TO THE TIBIAL INTERFACE UNDERSIDE. THERE WAS ALSO SLIM TO NO BONE CEMENT IN THE KEELED PORTION OF THE TRAY. LEGAL CLAIM: IT WAS ALSO ALLEGED MEDICAL DEVICE REMOVAL, PAIN, DISCOMFORT, JOINT INSTABILITY AND WALKING DIFFICULTY. DOI: (B)(6) 2017. DOR: (B)(6) 2018; LEFT KNEE.

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

  MAUDE report 9458535 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED HYPERTROPHIC SYNOVIUM WITH A BIT OF METAL TINGE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9327934 ↗
• InjuryNov 7, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO EFFUSION AND LOOSENING OF BOTH THE TIBIAL TRAY AND FEMORAL COMPONENT 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) 2016; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Edema; No Code Available

  MAUDE report 9291791 ↗
• InjuryOct 18, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 30 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO END STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 3. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING AND PAIN. THE SURGEON INDICATED WITH GENTLE TAPPING THE TIBIAL TRAY WAS REMOVED AND SHOWED NO EVIDENCE OF CEMENT BONDING. HE REPORTED THE FEMUR WAS A LITTLE INTERNALLY ROTATED, SO WAS REVISED. THE SURGEON NOTED PATELLAR MALTRACKING, SO WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; (LT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9209654 ↗