ATTUNE 1516-20-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295045656), received between Jul 19, 2018 and Apr 8, 2026 — classified as 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (3 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNEE IMPLANTED ON (B)(6) 2022. SINCE THAT TIME, THEY HAVE FALLEN AND TORN THEIR PCL AND NEEDED TO BE UPSIZING FROM 6 MM POLY TO A 12 MM POLY. DOI: (B)(6) 2022, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24817378 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED WITH POLY SWAP FOR I&D. REPORTEDLY THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PATIENT IS CURRENTLY DOING WELL. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865425 ↗
• InjuryJul 8, 2025Naturally Worn; Naturally Worn

  ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2025, THE PATIENT HAD A LEFT TOTAL REVISION TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT WITH DEBONDING OF THE CEMENT, MEDICAL POLYETHYLENE WEAR WITH SOME OSTEOLYSIS, MILD MID FLEXION INSTABILITY WITH EXTERNAL ROTATION OF THE FEMORAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE PAIN. DOI: (B)(6) 2016, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 22440776 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO LOOSE INTERFACE. THE INSERT WAS REMOVED AND REPLACED WITH A THICKER OPTION.

  Patient problems: Joint Laxity

  MAUDE report 22337502 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND SWITCHED TO A THICKER INSERT DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22106983 ↗
• InjuryApr 29, 2025Adverse 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. UNKNOWN SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21926153 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: DID SUBJECT REPORT ANY NEW AES OR ANY UPDATES TO AN EXISTING AE AT THIS EVALUATION?: YES. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE LOCATION: KNEE. TREATMENT/IMPACT: NO REMOVAL/EXCHANGE/REVISION. ADDITIONAL EVENT INFORMATION: CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION: DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DEVICE LOCATION: LEFT KNEE. TREATMENT/IMPACT: ASPIRATION/DRAINAGE; RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2019.

  Patient problems: Swelling/ Edema

  MAUDE report 20332940 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: BLANK. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 20293191 ↗
• MalfunctionSep 6, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLY WOULD NOT LOCK INTO PLACE IN PRIMARY PROCEDURE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690493 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOSS OF RANGE OF MOTION. DOI: (B)(6), 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 17651506 ↗
• MalfunctionMay 25, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS INVOLVED IN A PRIMARY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004142 ↗
• 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 16843229 ↗
• 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 16831068 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PRIMARY KNEE WAS INITIALLY REVISED ON (B)(6) 2021 DUE TO INFECTION. DURING THAT PROCEDURE, THE PATIENT'S PRIMARY TIBIAL INSERT WAS REMOVED, HER KNEE WAS IRRIGATED AND DEBRIDED, AND A REPLACEMENT TIBIAL INSERT WAS IMPLANTED. THE PATIENT'S KNEE WAS REVISED A SECOND TIME ON (B)(6) 2022 DUE TO TIBIAL SUBSIDENCE. WHEN THE PATIENT'S LOOSE TIBIAL TRAY WAS REMOVED, THE INTRAMEDULLARY CANAL APPEARED TO BE INFECTED. ALL OF THE PATIENTS KNEE REPLACEMENT COMPONENTS WERE THEREFORE REMOVED AND REPLACED BY A STATIC ANTIBIOTIC SPACER. THERE WAS A REPORTED TIBIAL LOOSENING OF BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2021 (ALL COMPONENTS); (B)(6) 2021 (TIBIAL INSERT). DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15996143 ↗
• 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 ON (B)(6) 2018 AT THE SAME HOSPITAL. DOI: (B)(6) 2018. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15892965 ↗
• 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 15872768 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2019; DATE OF REVISION: (B)(6) 2022; (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Osteolysis; Pain

  MAUDE report 15312852 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA. DATE OF MANIPULATION: (B)(6) 2021; PRE-MANIPULATION (IN DEGREES): EXTENSION: 5; FLEXION: 90; POST-MANIPULATION (IN DEGREES): EXTENSION: 0; FLEXION: 125.

  Patient problems: Adhesion(s)

  MAUDE report 13619717 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SURGERY FOR FRONT KNEE PAIN. SURGEON RESURFACED BOTH PATELLAS AS THEY WERE NOT RESURFACED DURING THE ORIGINAL SURGERY IN 2016. SURGEON ALSO EXTRACTED THE ATTUNE CVD SIZE 6 AND SIZE 5 INSERT DURING THE CASE. NEW ATTUNE CURVED INSERTS MATCHING THE ORIGINAL SIZES WERE IMPLANTED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. ORIGINAL SURGERY DATE WAS (B)(6) 2016 AT (B)(6) MEDICAL CENTER. THIS WAS BILATERAL KNEE SURGERY; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12323997 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DURING THE PROCEDURE, THE PATIENT PRIMARY TIBIAL INSERT WAS REMOVED. KNEE WAS THEN IRRIGATED & DEBRIDED AND A REPLACEMENT TIBIAL INSERT WAS IMPLANTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12199344 ↗
• InjuryMay 26, 2021Naturally Worn; Naturally Worn

  MEDICAL RECORDS WERE REVIEWED. PRIMARY OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, SWELLING AND INSTABILITY. UPON ENTERING THE JOINT, SYNOVITIS AND EVIDENCE OF POLYWEAR WAS ENCOUNTERED. INSERT WAS REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2018, DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11882802 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS INSTABILITY, ARTHROFIBROSIS, AND LOOSENING. LOOSENING WAS GIVEN AS THE PRE- AND POST-OPERATIVE DIAGNOSIS, HOWEVER, THE LOOSE COMPONENT AND INTERFACE WERE NOT INDICATED WITHIN THE OPERATIVE NOTE. THE SURGEON NOTED RESECTION OF EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENTS 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) 2019; RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 11826584 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT 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 RIGHT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR COMPONENTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11791716 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WOUND BREAKDOWN TKR. WOUND DEBRIDEMENT AND PROPHYLACTIC POLY CHANGE. PRIMARY TKR (B)(6) 2021. AT (B)(6) - RIGHT SIDE.

  Patient problems: Hematoma; Necrosis; Wound Dehiscence

  MAUDE report 11712279 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY EXCHANGE AND ADDED PATELLA COMPONENT FOR PAIN AND INSTABILITY. ORIGINAL SURGERY DETAILS UNKNOWN FROM A PUBLIC HOSPITAL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11039511 ↗