SMARTSET 3102-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10603295168355), received between Jul 24, 2017 and Jul 29, 2026 — classified as 75 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (53 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 75 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Loss of or Failure to Bond

  It was reported that the patient experienced aseptic tibial loosening. Tibia loosened at the cement/implant interface. All components were revised. Femur was not loose. No patient injury or delay.DOI: Unknown. DOR: On (b)(6) 2026.Affected side: Right Knee.

  Patient problems: Insufficient Information

  MAUDE report 50073333 ↗
• InjuryOct 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT THE IMPLANT CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23380823 ↗
• InjuryJul 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ASEPTIC TIBIAL LOOSENING OCCURRED BETWEEN THE TRAY AND CEMENT INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22675789 ↗
• InjuryJan 28, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE INSERT HAD A POSTERIOR MEDIAL CRACK IN IT AND PATELLA COMPONENT WAS LOOSE. THE LOOSENING INTERFACE OF THE PATELLA COMPONENT IS CEMENT/IMPLANT. BOTH WERE EXCHANGED FOR NEW IMPLANTS. THERE WAS NO SURGICAL DELAY AND ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: ON (B)(6) 2008, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21257494 ↗
• InjurySep 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. FEMORAL COMPONENT LOOSENED AT THE CEMENT AND BONE INTERFACE. TIBIAL COMPONENT LOOSENED AT THE TRAY AND CEMENT INTERFACE. DOI: (B)(6) 2008 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20128624 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: SEPTIC SHOCK DEVICE AND PROCEDURE (RELATEDNESS): NO INFORMATION PROVIDED DATE OF EVENT: 04-NOV-2021, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT KNEE. TREATMENT/IMPACT: REQUIRES INPATIENT HOSPITALIZATION/RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Septic Shock

  MAUDE report 20124740 ↗
• InjuryNov 7, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT IMPLANTS PUT KNEE AT 7 DEGREES MORE VALGUS THAN WHAT THE NATIVE KNEE WAS ORIGINALLY. FEMORAL AND TIBIAL COMPONENTS WERE LOOSE. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18083308 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 16272610 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 12 OCT 2022. PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS ON (B)(6) 2022. LEGAL CLAIM ALLEGES THE PATIENT SUFFERED FROM PAIN, DISABILITY, AND ADDITIONAL SURGERY. NO PRIMARY OR REVISION NOTES HAVE BEEN PROVIDED - ONLY THE PART/LOT INFORMATION FOR THE IMPLANTS PLACED. THIS PC CAPTURES THE LEFT KNEE WHICH IS CAPTURED ON PAGES 4 AND 5. (B)(4) CAPTURES THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15691458 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 12 OCT 2022. PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS ON (B)(6) 2022. LEGAL CLAIM ALLEGES THE PATIENT SUFFERED FROM PAIN, DISABILITY, AND ADDITIONAL SURGERY. NO PRIMARY OR REVISION NOTES HAVE BEEN PROVIDED - ONLY THE PART/LOT INFORMATION FOR THE IMPLANTS PLACED. THIS PC CAPTURES THE RIGHT KNEE WHICH IS CAPTURED ON PAGES 3 AND 4. (B)(4) CAPTURES THE LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15690876 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED. UPON FURTHER REVIEW IN THE DATA BASE BY CLINICIANS, THERE WAS NO REVISION, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA. ALL COMPONENTS WILL BE REPORTED. DATE OF IMPLANT: (B)(6) 2014. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE).

  Patient problems: Insufficient Information

  MAUDE report 15508775 ↗
• InjuryApr 21, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED TO ADDRESS SEVERE PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS LOOSE AT AN UNKNOWN INTERFACE. THE PATELLA AND FEMORAL COMPONENTS WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED AN ATTUNE TIBIAL REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14167757 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION KNEE SURGERY IN (B)(6) 2020. PATIENT APPEARED IN THE EMERGENCY ROOM WITH AN INFECTED TOTAL KNEE. SURGEON REMOVED DISTAL FEMUR AND INSERT AND PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REPLACED THE PARTS REMOVED WITH THE SAME SIZES BUT NEW IMPLANTS. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14075462 ↗
• InjuryNov 23, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO DELAY IN SURGERY. REPLACED WITH AN ATTUNE REVISION TIBIA WITH SLEEVE. DOI: (B)(6) 2016. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12861601 ↗
• InjuryNov 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE KNEE INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. DATE OF I & D: (B)(6) 2021. (LEFT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION: LEFT KNEE ASPIRATION; I & D.

  Patient problems: Unspecified Infection

  MAUDE report 12849998 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DISRUPTION OF ARTHROTOMY (WOUND DEHISCENCE). EVENT IS NOT SERIOUS AND IS CONSIDERED MILD, EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: SURGICAL REPAIR OF ARTHROTOMY, WITH NO REVISION OF PRODUCTS.

  Patient problems: Wound Dehiscence

  MAUDE report 12577031 ↗
• InjurySep 13, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ASEPTIC LOOSENING OF THE PATELLA. ORIGINAL SURGERY DONE (B)(6) 2008 AT RUTLAND REGIONAL MEDICAL CENTER BY THE SURGEON. RIGHT KNEE. DEPUY CEMENT WAS USED - SMARTSET MV BONE CEMENT. DOI: (B)(6) 2008, DOR: UNKNOWN, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12460044 ↗
• InjuryJun 14, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, THE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THE SURGEON NOTED THE REMOVAL OF A SCREW FROM THE RIGHT KNEE FROM AN UNKNOWN MANUFACTURER IMPLANTED DURING A PREVIOUS OPERATION FOR AN UNKNOWN REASON. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF EXCESS SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND DEPUY CEMENT X 1. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2019; RIGHT SIDE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 11992311 ↗
• InjuryApr 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED PRIMARY ATTUNE TKA TO TREAT SEVERE DJD. THE PATELLA WAS RESURFACED AND COMPETITOR DEPUY X 1 WAS UTILIZED. THE SURGEON NOTES THE PATIENT HAD PREEXISTING FLEXION CONTRACTURE AND VALGUS DEFORMITY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. 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. PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016 DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11726127 ↗
• InjuryMar 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FALL ABOUT 1 YEAR AGO, HAS BEEN PAINFUL SINCE AND LOOSENING OF THE TIBIAL BASE FB COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. INTRA-OP FAILED TIBIAL COMPONENT. DOI: (B)(6) 2014 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 11446316 ↗
• InjurySep 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT SEVERE OSTEOARTHRITIS. INTRAOPERATIVELY, THE SURGEON NOTES THERE WAS OBLITERATION OF THE MEDIAL JOINT. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN AND DISCOMFORT SECONDARY TO TIBIAL TRAY LOOSENING AND MIGRATION. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND EASILY REMOVED. THE FEMORAL COMPONENT WAS WELL-FIXED AND RETAINED. THE PATELLA WAS WELL FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED DEPUY REVISION COMPONENTS UTILIZING DEPUY CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. INTRAOPERATIVE PATHOLOGY INDICATED 1 PAIR OF GRAM POSITIVE COCCI BUT 3 DAY GROWTH WAS NEGATIVE FOR INFECTION. DOI: (B)(6) 2014, DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 10504591 ↗
• InjurySep 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  KNEE REVISION - ATTUNE TKA. PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO LEFT KNEE OSTEOARTHRITIS AND PAIN. DEPUY CEMENT X1 WAS UTILIZED DURING SURGERY. THE PATIENT HAD A LEFT KNEE REVISION ARTHROPLASTY OF TIBIAL COMPONENT TO ADDRESS PAIN, LOOSENING OF TIBIAL TRAY AT BONE/TRAY INTERFACE, AND ARTHROFIBROSIS. DURING THE PROCEDURE, THE SURGEON NOTED EFFUSION AND MODERATE SYNOVITIS. THERE WERE NO ALLEGATIONS OF DEFICIENCY OF THE FEMORAL COMPONENT, INSERT OR PATELLA.

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

  MAUDE report 10487869 ↗
• InjuryJul 31, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10350502 ↗
• InjuryApr 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE SYSTEM FOR UNKNOWN REASONS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X1 WAS UTILIZED. THE PRIMARY OPERATIVE NOTES WERE NOT PROVIDED. PATIENT RECEIVED A LEFT REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON ENCOUNTERED AND REMOVED SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AT AN UNKNOWN INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9981921 ↗
• InjuryApr 17, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED, HOWEVER, THE HOSPITAL BUYS IN BULK AND HAS NO IDEA OF THE LOT NUMBER. SHE HAD STATED TO THE SURGEON THAT SHE HAD FALLEN A SHORT TIME AFTER HER PRIMARY SURGERY AND EVENTUALLY HAD INCREASED PAIN IN HER KNEE. SURGEON CHOSE TO REVISE BOTH TIBIAL BASEPLATE AND FEMORAL COMPONENT. TIBIAL BASEPLATE WAS FOUND TO BE GROSSLY LOOSE WITH NO CEMENT ADHERED TO TRAY, ONLY THE TIBIAL PLATEAU SURFACE. FEMORAL COMPONENT WAS FOUND TO HAVE ADEQUATE FIXATION, HOWEVER SOME OSTEOLYTIC TRACTS HAD FORMED IN A COUPLE OF PLACE UNDER THE DISTAL CONDYLES AND THEREFORE THE SURGEON CHOSE TO REVISE TO POTENTIALLY PREVENT A THIRD OPERATION IN A FEW YEARS. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9972791 ↗