ATTUNE 1506-10-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 10603295042624), received between Jul 14, 2017 and Nov 13, 2025 — classified as 190 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (141 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 192 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS ENTITLED (B)(4) LITIGATION RECORDS AD 09 FEB 2026 HAVE BEEN REVIEWED BY A CLINICIAN. DOI (B)(6) 2017: MALE PATIENT RECEIVED A LEFT DEPUY ATTUNE PRIMARY KNEE TO TREAT SEVERE DJD. THE PATELLA WAS NOT RESURFACED, AND THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITH DEPUY SMARTSET CEMENT X2. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PART/LOT INFORMATION IS PROVIDED ON PP.5-6. DOR (B)(6) 2022: 58-YEAR-OLD MALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT CHRONIC PAIN, INSTABILITY, AND WALKING DIFFICULTY SECONDARY TO FEMORAL OSTEOLYSIS AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED FEMORAL OSTEOLYSIS AND ABUNDANT FEMORAL OSTEOPHYTES. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REMOVED. FEMORAL OSTEOLYSIS WAS CURETTED WHEN THE FEMORAL COMPONENT WAS REMOVED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE POSTOPERATIVE SWELLING AND VENOUS DOPPLER NOTED ON (B)(6) 2022 WAS RELATED TO THE COMPETITOR KNEE AND NOT ASSOCIATED WITH A DEPUY DEVICE OR PROCEDURE. A

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

  MAUDE report 23540952 ↗
• InjuryNov 3, 2025Migration; Migration

  IT WAS REPORTED A REVISION OF AN RIGHT-SIDE FEMUR ATTUNE PSRP OCCURRED ON (B)(6) 2025 DUE TO A FALL AND LOOSE FEMUR CONSTRUCT. IT ALSO LOOKED LIKE THE TIBIA SUBSIDED SLIGHTLY. ALL COMPONENTS WERE REMOVED EXCEPT THE PATELLA. THE FEMUR WAS LOOSE AND CAME OUT WITH NO CEMENT ON THE LATERAL SIDE OF THE FEMORAL COMPONENT. THE MEDIAL SIDE OF THE IMPLANT HAD CEMENT ON IT. THE TIBIA CAME OUT CLEAN WITH NO CEMENT ON IT, BONE/CEMENT INTERFACE WAS INTACT. NO ALLEGATION MADE AGAINST THE PATELLA COMPONENT OR CEMENT. PATELLA COMPONENT WAS NOT REVISED. THE CONSTRUCT WAS IMPLANTED ON (B)(6) 2017.

  Patient problems: Fall

  MAUDE report 23449559 ↗
• InjuryApr 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO MASSIVE JOINT EFFUSION. THERE WAS A POSSIBLE LOOSE TIBIA. LOOSENING INTERFACE IS CEMENT/IMPLANT. THE CEMENT MANUFACTURER IS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 21853994 ↗
• InjuryJan 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION - ASEPTIC. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: RIGHT KNEE. TREATMENT/IMPACT: REVISION FOR ASEPTIC LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 21244975 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL ATTUNE KNEE DONE. THE PATIENT WAS INFECTED, SO ALL COMPONENTS WERE REMOVED AND TEMPORARY PARTS IMPLANTED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19593226 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED BILATERAL TKA. FOLLOWING SURGERY, PATIENT WAS SATISFIED WITH RIGHT SIDE. HOWEVER LEFT SIDE HAS GIVEN CONSISTENT PAIN ISSUE EVER SINCE OPERATION. NO VISIBLE LOOSENING ON X-RAY AND NO EVIDENCE OF INFECTION. DECISION WAS MADE TO REVISE LEFT TKA TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 18856154 ↗
• InjuryJun 2, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17050213 ↗
• InjuryApr 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY ATTUNE IMPLANTED APPROX 6 YEARS AGO AT ANOTHER HOSPITAL, UNABLE TO OBTAIN ACTUAL DATES. PRESENTED TO SURGEON'S CLINIC WITH PAIN IN HIS LEFT KNEE. CT SCAN AN X-RAY WERE TAKEN AND THIS SHOWED THAT THE IMPLANTS WERE LOOSE AND NEEDED TO BE REVISED.

  Patient problems: Inflammation; Pain

  MAUDE report 16712653 ↗
• InjuryJan 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16272552 ↗
• InjuryNov 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA IMPLANT DIDN¿T HAVE A LINK TO THE CEMENT AND WAS LOOSE. PATIENT EXPERIENCED LATE INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 15794513 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASH OUT FOR INFECTION. THE LOT'S WERE NOT PROVIDED. LEFT KNEE WASHOUT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT? (B)(6) MEDICAL CENTER, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: SEPTIC KNEE, DID PATIENT REQUIRE REVISION SURGERY? FALSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE. REMOVAL OF HARDWARE, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, ACTIVITY LEVEL: HIGH, (B)(4) DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: NONE, (B)(4) DEVICE PROPERTY OF: HOSPITAL, DEVICE IN PO

  Patient problems: Unspecified Infection

  MAUDE report 15115535 ↗
• InjuryJul 18, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO AN INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. THE FEMUR, TIBIA, AND THE POLY WERE REMOVED. DEPUY CEMENT WAS USED. NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15040949 ↗
• InjuryApr 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING OF THE RIGHT TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 14210054 ↗
• InjuryApr 22, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. THE PARTS WERE REVISED AND EXPLANTED AND NEW PARTS IMPLANTED USING A COMPETITORS KNEE REVISION SYSTEM. NO SURGICAL DELAY. DOI: (B)(6) 2016; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14188064 ↗
• InjuryFeb 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO TIBIAL LOOSENING AND PAIN. DOI: UNK. DOR: (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 13505827 ↗
• InjuryDec 3, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO INTRAOP DELAY. THERE WAS A REVISION SURGERY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 12925573 ↗
• InjuryNov 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING ON THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. THE TIBIAL COMPONENT WAS GROSSLY LOOSE , CAME OUT WITH NO CEMENT ON TRAY. IMPLANT IS CHAIN OF CUSTODY AND WILL NOT BE RETURNED. NO SURGICAL DELAY. DOI: UNKNOWN, DOR:(B)(6), 2021, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12882146 ↗
• InjuryNov 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  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, SWELLING, SYNOVITIS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL INSERT, TIBIAL TRAY, 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) 2017. DOR: (B)(6) 2020 . RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 12825033 ↗
• InjuryNov 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  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, SWELLING, SYNOVITIS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL INSERT, TIBIAL TRAY, 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) 2017, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 12825025 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OSTEOLYSIS/LUCIENCIES/MIGRATION/LOOSENING - FEMORAL EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. PRIMARY OPERATIVE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A RIGHT 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) 2017 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO OSTEOLYSIS, EFFUSION AND PAIN. UPON ENTERING THE JOINT, THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE. THE FEMORAL, TIBIAL AND INSERT COMPONENTS REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DATE OF IMPLANTATION: (B)(6) 2013. DATE OF EVENT (ONSET): (B)(6) 2016 (RIGHT KNEE).

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12715313 ↗
• InjuryAug 26, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT RECEIVED A RIGHT REVISION OF AN UNKNOWN UNICOMPARTMENTAL KNEE TO TREAT ASEPTIC LOOSENING. A PRIMARY ATTUNE KNEE WAS IMPLANTED. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT¿S RIGHT KNEE WAS REVISED TO TREAT PAIN, INSTABILITY, LOSS OF FUNCTION, AND SWELLING SECONDARY TO SUSPECTED TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, A LARGE EFFUSION WAS EVACUATED. THE SURGEON IDENTIFIED AND EXCISED EXTENSIVE PERIARTICULAR HYPERTROPHIC SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR. UPON INSPECTION, THE SURGEON IDENTIFIED WEAR AND A COLD-FLOW DEFORMATION ON THE INSERT, WITH NOTABLE BACKSIDE WEAR. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE SURGEON NOTES THE TIBIAL TRAY HAD MOVED INTO VARUS DUE TO AN OSTEOLYTIC LESION ALONG THE MEDIAL TIBIAL PLATEAU THAT THE SURGEON ATTRIBUTED TO THE POLY DEBRIS GENERATED BY THE WEAR FROM THE INSERT. THE FEMORAL COMPONENT WAS WELL FIXED BUT REVISED TO ACCOMMODATE THE REVISION KNEE DEVICES. THE PATELLA WAS WELL-FIXED WITH NO SIGNS OF WEAR AND RETAINED. THE PATIENT WAS REVISED WITH AN UNKNOWN REVISION KNEE SYSTEM. THE PROCEDURE WAS

  Patient problems: Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12370822 ↗
• InjuryJun 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS GROSS LOOSENING OF BOTH FEMUR AND TRAY AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. POSITIVE INFECTION PRESENT SO ALL IMPLANTS EXPLANTED AND ANTIBIOTIC SPACER WAS IMPLANTED. UNKNOWN BONE CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12089668 ↗
• InjuryJun 10, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION FOR DEBONDING OF ATTUNE RP TIBIA FROM CEMENT.

  Patient problems: Insufficient Information

  MAUDE report 11977435 ↗
• InjuryJun 3, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT SEVERE OSTEOARTHRITIS WITH VALGUS DEFORMITY. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. OF NOTE- THE PATELLA SUSTAINED A LATERAL CRACK DURING PATELLAR RESECTION. THE SURGEON DID NOT TREAT THE CRACK AS THE AREA WAS INVESTED WITH THE TENDON. HE CEMENTED THE PATELLAR BUTTON, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT ASEPTIC LOOSENING. UPON ENTERING THE JOINT, SOME PERIPATELLAR SCAR TISSUE WAS DEBRIDED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED WITH MINIMAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND TRACKED NICELY WITH THE DEPUY PFC SIGMA REVISION CONSTRUCT AND WAS THUS RETAINED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2019. RIGHT KNEE

  Patient problems: Adhesion(s)

  MAUDE report 11930356 ↗
• InjuryMay 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. THE SURGEON IMPLANTED A REVISION FB TIBIAL COMPONENT WITH A PS FB POLY. THE PATIENT WANTED TO KEEP THE IMPLANTS. THE SURGEON PERFORMED THE INITIAL TKA PROCEDURE. DOI: (B)(6) 2017. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11850551 ↗