SMARTSET 3122-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 824 adverse event reports that list this exact device (DI 10603295168379), received between Jul 20, 2017 and May 18, 2026 — classified as 777 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (639 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 824 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Loss of or Failure to Bond

  IT WAS REPORTED ON 08-28-2017, PATIENT RECEIVED AN ATTUNE LEFT POSTERIOR STABILIZED, FIXED BEARING TOTAL KNEE REPLACEMENT, UTILIZING TRUMATCH TECHNOLOGY. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO COMPLICATIONS. DEPUY SMARTSET BONE CEMENT WAS USED. ON (B)(6) 2018, LEFT KNEE WAS REVISED TO ADDRESS LEFT KNEE TIBIAL IMPLANT LOOSENING, AT THE CEMENT TO IMPLANT INTERFACE. INTRAOPERATIVELY, THE FEMUR AND PATELLA WERE FOUND TO BE WELL-FIXED, BUT THE TIBIAL TRAY WAS GROSSLY LOOSE, COMPLETELY DEBONDED FROM THE CEMENT MANTLE, AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE ALL REVISED, AND REPLACED WITH COMPETITOR REVISION COMPONENTS. THE DEPUY ATTUNE PATELLA WAS RETAINED. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2018 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25199813 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AND A STAGE 1 KNEE REVISION. THEY PUT IN A TEMPORARY ANTIBIOTIC SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24053268 ↗
• MalfunctionNov 12, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT LIQUID VIAL IN CEMENT BROKE IN PACKAGING BEFORE BEING OPENED. IT WAS UNABLE TO BE USED IN SURGERY. AFFECTED SIDE: UNKNOWN KNEE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534761 ↗
• InjuryOct 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE CLINIC WITH XRAYS THAT WERE SUSPICIOUS OF ASEPTIC LOOSENING ON THE ANTERIOR FLANGE OF TKA FEMUR AND LATERAL PROXIMAL TIBIA. PRODUCT STATED TO BE LOOSE: FEMUR/TIBIA. LOOSENING INTERFACE: BONE TO CEMENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23378341 ↗
• InjuryOct 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE CLINIC WITH XRAYS THAT WERE SUSPICIOUS OF ASEPTIC LOOSENING ON THE ANTEROIR FLANGE OF TKA FEMUR AND LATERAL PROXIMAL TIBIA. PRODUCT STATED TO BE LOOSE: FEMUR/TIBIA. LOOSENING INTERFACE: BONE TO CEMENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23378328 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED BY THE SURGEON. THERE WAS NO DELAYS IN SURGERY OR ANY PATIENT INJURY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22496714 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION IN THE TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED BY THE SURGEON. THERE WAS NO DELAYS IN SURGERY OR ANY PATIENT INJURY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE,

  Patient problems: Unspecified Infection

  MAUDE report 22496577 ↗
• MalfunctionMay 13, 2025Chemical Problem; Chemical Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? PATIENT OUTCOME WAS NOT AFFECTED AS THE DOCTOR NOTICED THE ISSUE AND REQUESTED A NEW BATCH OF CEMENT AND A NEW TIBIA BASEPLATE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009793 ↗
• MalfunctionMay 13, 2025Chemical Problem; Chemical Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? PATIENT OUTCOME WAS NOT AFFECTED AS THE DOCTOR NOTICED THE ISSUE AND REQUESTED A NEW BATCH OF CEMENT AND A NEW TIBIA BASEPLATE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009762 ↗
• 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 21926317 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD 3 RIGHT KNEE REPLACEMENTS, FIRST ONE IN 2021 AND MOST RECENT ONE BEING 2022. THE PATIENT STATED AFTER EACH KNEE REPLACEMENT SHE EXPERIENCED RIGHT LEG SWELLING AND PAIN.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 21263321 ↗
• InjuryJan 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO TREAT PERSISTENT GLOBAL INSTABILITY. THE PATIENT HAD A PREVIOUS REVISION OF THE TIBIAL INSERT TO TREAT INSTABILITY AND POLY-WEAR ON (B)(6) 2018 ((B)(4)) UPON ENTERING THE JOINT, THE SURGEON NOTED THE TIBIAL TRAY WAS STABLE BUT MILDLY LOOSENED AT THE SMART-SET CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS STABLE BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED UNKNOWN TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A DEPUY ATTUNE STEMMED REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2018. DOR (B)(6) 2018 (PRIMARY TIBIAL INSERT CAPTURED ON (B)(4)). DOR: (B)(6) 2023 (UNK INSERT, FEMORAL, TRAY, CEMENT). LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21201124 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Device Damaged Prior to Use; Fluid/Blood Leak; Device Damaged Prior to Use

  IT WAS REPORTED THAT VIAL OF LIQUID IN CEMENT BOX WAS CRACKED AND LEAKING. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735985 ↗
• InjuryNov 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT TKA DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS USED. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF THE LEFT TKA DUE TO FAILED KNEE. THE TIBIAL COMPONENT WAS NOTED TO LOOSE AND WAS REMOVED FROM THE CEMENT VERY EASILY. THE FEMORAL COMPONENT, PATELLA, AND INSERT WERE ALSO REVISED, BUT THERE WERE NO ALLEGATIONS REPORTED AGAINST THOSE PRODUCTS. COMPETITOR IMPLANTS AND CEMENT WERE PLACED AT REVISION. DOI: ON (B)(6) 2016. DOR: ON (B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20704920 ↗
• InjuryNov 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT TKA DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS USED. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF THE LEFT TKA DUE TO FAILED KNEE. THE TIBIAL COMPONENT WAS NOTED TO LOOSE AND WAS REMOVED FROM THE CEMENT VERY EASILY. THE FEMORAL COMPONENT, PATELLA, AND INSERT WERE ALSO REVISED, BUT THERE WERE NO ALLEGATIONS REPORTED AGAINST THOSE PRODUCTS. COMPETITOR IMPLANTS AND CEMENT WERE PLACED AT REVISION. DOI: ON (B)(6) 2016. DOR: ON (B)(6) 2021. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20672794 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS INSTABILITY. INTRAOPERATIVELY, IT WAS IDENTIFIED THAT THE TIBIAL BASE PLATE WAS LOOSE (INTERFACE NOT PROVIDED) AND HAD SUBSIDED. IT WAS ALSO NOTED THAT THE WELL-FIXED FEMUR WAS MALPOSITIONED/INTERNALLY ROTATED AND WAS EXPLANTED ALONG WITH THE TIBIAL TRAY AND INSERT. THE PATELLA COMPONENT WAS WELL-FIXED AND WAS RETAINED. REVISION TIBIAL TRAY AND REVISION FEMUR, WITH SLEEVE AND STEM FOR BOTH SIDE CONSTRUCTS WERE IMPLANTED, THERE WERE NO COMPLICATIONS REPORTED. NO PRODUCT INFORMATION WAS PROVIDED IN THE RECORDS FOR REVISED PRIMARY IMPLANTS OR RETAINED PATELLA. THE RECORDS DID PROVIDE A PARTIAL RECORD OF THE REVISION IMPLANTS PLACED DURING (B)(6) 2018 REVISION--THESE APPEAR TO BE ONLY FOR THE FEMUR SIDE OF THE KNEE (DEPUY FEMUR, AUGMENTS, SLEEVE, AND STEM, AS WELL AS DEPUY CEMENT). ON (B)(6) 2022, PATIENT'S LEFT KNEE WAS REVISED AGAIN TO ADDRESS SEVERE PAIN AND GROSS INSTABILITY. INTRAOPERATIVELY, THE WELL-FIXED FEMUR COMPONENTS WERE EXPLANTED FROM THE FEMORAL SLEEVE AND STEM, WHICH WERE WELL-FIXED AND RETAINED. AN S-ROM NOILES HINGED FEMUR WITH 2 FEMORAL AUGMENTS WAS IMPLANTED ALONG WITH 12MM THICK HINGED

  Patient problems: Joint Laxity; Pain

  MAUDE report 20658396 ↗
• MalfunctionAug 13, 2024Missing Information; Missing Information

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ADVERSE CONSEQUENCE AND NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971921 ↗
• MalfunctionAug 13, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT CEMENT CAME WITHOUT STICKERS. DOE: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971918 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19938123 ↗
• InjuryJun 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY INVOLVING ATTUNE COMPONENTS. THE PATELLA WAS RESURFACED AND SMARTSET CEMENT X 2 WAS USED. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR INSTABILITY. INTRAOPERATIVELY, THE TIBIAL COMPONENT WAS COMPLETELY DEBONDED AT AN UNKNOWN INTERFACE. THE PATIENT HAD SEVERE OSTEOLYSIS AND A TIBIAL PLATEAU FRACTURE. THE FRACTURE WAS REPAIRED WITH A SMALL TRABECULAR METAL CONE AND BONE GRAFTS. COMPETITOR PRODUCTS WERE PLACED DURING THE REVISION WHILE THE ATTUNE PATELLA WAS LEFT IN SITU. DOI: (B)(6) 2015 DOR: (B)(6) 2024 (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 19637667 ↗
• MalfunctionJun 21, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT CEMENT BOX DID NOT CONTAIN A PATIENT LABEL. THE BOX LABEL AND PACKAGE LABELS MATCHED. PRODUCT WAS USED. THERE WAS NO DELAY OR HARM TO PATIENT. DOE: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583246 ↗
• MalfunctionJun 7, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT DEPUY CEMENT DID NOT HAVE STICKERS IN THE BOX.

  Patient problems: Insufficient Information

  MAUDE report 19488386 ↗
• MalfunctionJun 4, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT THERE WAS NO PATIENT LABELS INSIDE THE BOX. BOX LABEL MATCHED PACKAGE LABELS WITH ITEM, LOT AND EXPIRATION. PRODUCT WAS USED. THERE WERE NO DELAYS OR DAMAGE TO PATIENT. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457479 ↗
• MalfunctionJun 3, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT CEMENT BOX DID NOT CONTAIN PATIENT LABEL INSIDE BOX. OUTSIDE LABEL AND PACKAGE LABELS MATCHED AND HAD LOT AND EXPIRATION. THERE WERE NO DELAYS AND PATIENT WAS NOT INJURED. PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455519 ↗
• MalfunctionJun 3, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT CEMENT BOX DID NOT CONTAIN PATIENT LABEL INSIDE BOX. OUTSIDE LABEL AND PACKAGE LABELS MATCHED AND HAD LOT AND EXPIRATION. THERE WERE NO DELAYS AND PATIENT WAS NOT INJURED. PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455511 ↗