ATTUNE 1506-00-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295042365), received between Nov 26, 2017 and May 8, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (25 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 8, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING. TIBIAL BASEPLATE WAS EXPLANTED. IT WAS STATED THAT TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. COMPETITOR CEMENT WAS USED. AFFECTED SIDE: UNKNOWN

  Patient problems: Insufficient Information

  MAUDE report 25123135 ↗
• InjuryDec 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT TIBIAL COMPONENT APPEARED TO BE LOOSE THEREFORE REVISION SURGERY WAS PERFORMED. DURING SURGERY IT WAS CONFIRMED THAT TIBIAL COMPONENT WAS LOOSE. THE TIBIAL AND THE POLY WERE REMOVED AND REPLACED WITH DEPUY REVISION COMPONENTS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED DOI-UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23897695 ↗
• InjuryJan 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL TRAY LOOSENING AT CEMENT TO IMPLANT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16204136 ↗
• InjuryJan 7, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE SO THE SALES REP PULLED THE TIBIA AND REPLACED WITH AN ATTUNE REVISION TIBIA AND STEM AND SLEEVE. THE CEMENT WAS HOSPITAL OWNED SO THE SALES REP DOES NOT HAVE THE LOT NUMBERS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 13193025 ↗
• InjurySep 30, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  TIBIAL ASEPTIC LOOSENING AT THE CEMENT/IMPLANT INTERFACE. NOT CEMENT FROM DEPUY. IMPLANTED (B)(6) 2018.

  Patient problems: Pain

  MAUDE report 12558886 ↗
• InjuryAug 24, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. SURGEON EXPLANTED COMPONENTS REVISING WITH CRS. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12359551 ↗
• InjuryFeb 24, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CEMENT WAS NOT MANUFACTURED BY DEPUY. SURGERY TIME WAS NOT EXTENDED. THE EVENT DESCRIPTION STATES, "ASEPTIC TIBIAL LOOSENING". CEMENT TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 11373763 ↗
• InjuryJan 12, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND COMPETITOR 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 AND LOOSENING OF THE TIBIAL COMPONENT. UPON ENTERING THE JOINT, PROFOUND STIFFNESS AND SIGNIFICANT ADHESIONS WERE ENCOUNTERED AND REMOVED. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, INSERT AND TIBIAL COMPONENT WERE REVISED. DEPUY PRODUCTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 11155076 ↗
• InjuryJan 12, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS NOT RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, IT IS INDICATED THAT SCARRING WAS REMOVED. THE TIBIAL COMPONENT WAS LOOSE, INTERFACE NOT PROVIDED. THE FEMORAL AND INSERT COMPONENTS WERE ALSO REVISED WITHOUT INDICATION OF PRODUCT DEFICIENCY. DEPUY PRODUCTS WERE IMPLANTED, THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 11154961 ↗
• InjuryAug 26, 2020Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  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; Pain

  MAUDE report 10454761 ↗
• InjuryAug 17, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT TECHNICALLY, THE TIBIA WAS NOT LOOSE, HOWEVER AS SOON AS IT WAS TAPPED THE THE CEMENT/IMPLANT INTERFACE, IT POPPED OUT CLEAN.

  Patient problems: No Code Available; Pain

  MAUDE report 10416532 ↗
• InjuryJul 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF ATTUNE TIBIAL PLATEAU RIGHT SIDE BECAUSE OF LOOSENING. THERE HAS BEEN NO CEMENT ADHESION ON THE CEMENT TO METAL INTERFACE. DOI: (B)(6) 2016, DOR: (B)(6) 2020. A SURGICAL DELAY WAS NOT REPORTED.

  Patient problems: No Code Available

  MAUDE report 10231197 ↗
• InjuryMay 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT RHEUMATOID ARTHRITIS WITH DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED PERIARTICULAR SCAR TISSUE. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA AND FEMORAL COMPONENT WERE WELL FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED ATTUNE REVISION COMPONENTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10039074 ↗
• InjuryApr 23, 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

  PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 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 LOOSE TIBIAL COMPONENT, SEVERE FEMORAL BONE DEFECT WITH FEMORAL BONE CYST, SYNOVITIS AND EFFUSION. DEPUY IMPLANTS AND CEMENT WAS UTILIZED AT THE REVISION SURGERY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Edema; No Code Available

  MAUDE report 9991686 ↗
• InjuryApr 6, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED AN ATTUNE TOTAL KNEE TO TREAT LEFT KNEE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO TIBIAL TRAY LOOSENING. INTRAOPERATIVE FINDINGS CONFIRMED LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH ATTUNE PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9929167 ↗
• InjuryMar 25, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT ADVANCED DEGENERATIVE OSTEOARTHRITIS OF THE LEFT KNEE. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED COMPLICATIONS. PART/ LOT INFORMATION PROVIDED ON PAGE 6 OF THE MEDICAL RECORDS. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE KNEE, TIBIAL TRAY LOOSENING WAS CONFIRMED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND COMPLETELY DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS THEN IMPLANTED WITH DEPUY REVISION KNEE COMPONENTS UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9878628 ↗
• InjuryFeb 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT IN CEMENT TO IMPLANT INTERFACE. CAME OUT WITH NO CEMENT ON IMPLANT. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9765539 ↗
• InjuryNov 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN 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) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9327533 ↗
• InjuryNov 7, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 15 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. 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) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING AND INSTABILITY. THE SURGEON NOTED IN THE POST-OPERATIVE NOTES, THE TIBIAL COMPONENT WAS LOOSE. HE NOTED SEVERE SYNOVITIS, INSTABILITY, AND EFFUSION. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY CEMENT X 2. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2017, DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: Edema; No Code Available

  MAUDE report 9290771 ↗
• InjuryOct 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 18 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED 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) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT AND INSTABILITY. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE, WITH COMPLETE DEBONDING. HE NOTED THE FEMORAL COMPONENT WAS REVISED TO BETTER PAIR WITH THE REVISED TIBIAL COMPONENT. THE PATELLA WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017. DOR: (B)(6) 2018. (LT KNEE).

  Patient problems: No Code Available

  MAUDE report 9176720 ↗
• InjurySep 4, 2019Loss of or Failure to Bond; Malposition of Device; Unintended Movement; Loss of or Failure to Bond; Malposition of Device; Unintended Movement

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND INSTABILITY. THE SURGEON NOTED THE TIBIAL TRAY WAS MALPOSITIONED, SUBSIDED, AND LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS ALSO BONE LOSS TO THE FEMUR AND TIBIA. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014. DOR: (B)(6) 2017. LEFT KNEE.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 8959778 ↗
• InjuryJan 11, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT USED WAS FROM COMPETITOR.

  Patient problems: No Code Available; Pain

  MAUDE report 8239992 ↗
• InjuryOct 18, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AND TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: No Code Available

  MAUDE report 7980854 ↗
• InjurySep 6, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  NO CEMENT WAS FOUND/STICK ON THE TIBIAL BASE TRAY. AS A RESULT, KNEE REVISION WAS PERFORMED TO REMOVE THE IMPLANT.

  Patient problems: Not Applicable; Pain; Shock, Surgical

  MAUDE report 7851757 ↗
• InjuryMar 5, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS STATED TIBIAL LOOSENING. LOOSENING OCCURRED FROM CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS COMPETITOR. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7312688 ↗