SMARTSET 3122-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295168362), received between Oct 3, 2018 and Apr 5, 2022 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT THE 20G BATCH OF DEPUY SMARTSET MV CEMENT WAS OPENED FOR THE CASE. AS USUAL, THE TECH EMPTIED THE POWDER INTO THE VACUUM MIXING BOWL FOLLOWED BY THE LIQUID, PUT THE LID ON STEPPED ON THE FOOT PEDAL AND BEGAN TO MIX. AFTER ABOUT 45-60 SECONDS OF THE 90 SECOND PREFERRED MIX TIME, IT BECAME APPARENT THAT SOMETHING WAS NOT RIGHT. THE CEMENT WAS NOT THE RIGHT CONSISTENCY, IT APPEARED VERY CLUMPY AND DRY AS IF THERE WAS NOT ENOUGH LIQUID OR SOMETHING. THIS BATCH WAS DISPOSED OF, A NEW BATCH OF THE SAME LOT NUMBER WAS OPENED AND MIXED IN THE SAME FASHION AND THIS SECOND BATCH WAS PERFECTLY NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014664 ↗
• InjuryJan 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A LEFT ATTUNE 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 LEFT KNEE REVISION TO ADDRESS PAIN, OSTEOLYSIS, TIBIAL INSERT WEAR, TIBIAL BONE INJURY, TIBIAL TRAY MIGRATION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF FIBRINOUS TISSUE AS WELL AS REMOVAL OF MENISCUS OF TISSUE THAT HAD DEVELOPED AROUND THE POLY PATELLA COMPONENT. THE POLY PATELLA COMPONENT WAS INTACT WITH VERY LITTLE WEAR AND WAS RETAINED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 13170125 ↗
• MalfunctionOct 28, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THERE WAS A RISK TO PATIENT ASSOCIATED WITH IMPLANTATION OF EXPIRED BONE CEMENT. PRODUCT WAS IMPLANTED IN A PROCEDURE ON (B)(6) 2021 AND THE EXPIRATION WAS (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711525 ↗
• MalfunctionOct 27, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE SURGEON WAS INADVERTENTLY GIVEN AN ¿EXPIRED¿ ( DOE 8/31/2012) BAG OF CEMENT AND ABOUT HALF OF THAT BAG WAS COMBINED WITH OTHER FULL BAGS, THEN USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705839 ↗
• InjuryJun 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ATTUNE LITIGATION RECORD RECEIVED. LITIGATION RECORD ALLEGES SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY, DIFFICULTY AMBULATING, SWELLING AND ASEPTIC LOOSENING TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2016. DOR: (B)(6) 2020. LEFT KNEE.

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

  MAUDE report 12016109 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT HAD A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA WERE USED DURING THIS PROCEDURE. ON (B)(6) 2017 THE PATIENT HAD AN ASPIRATION AND INJECTION IN HIS LEFT KNEE TO ADDRESS PERSISTENT PAIN, SORENESS, AND SWELLING. DOI: (B)(6) 2016. DOE: (B)(6) 2017. LEFT KNEE

  Patient problems: Discomfort; Pain; Swelling/ Edema

  MAUDE report 12009450 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT INFECTION IS THE REASON FOR LOOSENING.

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

  MAUDE report 11418990 ↗
• InjuryFeb 8, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, EDEMA, OSTEOLYSIS, SYNOVITIS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY AND TIBIAL INSERT WERE REVISED. THE FEMORAL COMPONENT AND PATELLA COMPONENT WERE RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 11294432 ↗
• InjuryJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X2. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2019: THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE REPORTS OF PAIN, STIFFNESS, EDEMA, OBSERVABLE 5 DEGREES KNEE FLEXION CONTRACTURE AND SUSPECTED LOOSENING. INTRAOPERATIVE FINDINGS WERE EFFUSION AND SYNOVITIS ALONG WITH LOOSE TIBIAL TRAY AT IMPLANT-CEMENT INTERFACE. PATELLA AND FEMORAL COMPONENT NOT REVISED. ALL OTHER COMPONENTS (TIBIAL TRAY AND INSERT) WERE REPLACED WITH DEPUY REVISION SYSTEM WITH DEPUY CEMENT. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. DOI: (B)(6) 2018. DOR: (B)(6) 2019, (TIBIAL TRAY AND INSERT).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9547919 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED DUE TO LIGAMENTOUS INSTABILITY. (B)(6) 2013 PRIMARY OPERATIVE NOTES INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO LEFT KNEE DEGENERATIVE JOINT DISEASE. THIS PROCEDURE WAS COMPLETED WITHOUT COMPLICATION NOTED BY THE SURGEON. (B)(6) 2014 PROCEDURE NOTES INDICATE THE PATIENT RECEIVED A LEFT KNEE MANIPULATION UNDER ANESTHESIA DUE TO LEFT KNEE ARTHROFIBROSIS. (B)(6) 2014 OFFICE NOTES INDICATE THE PATIENT IS STATUS POST-MANIPULATION UNDER ANESTHESIA OF LEFT TOTAL KNEE. STATES HIS KNEE IS NOW DOING WELL WITH SOME UPPER QUAD-MUSCLE PAIN. AT THIS TIME LABS WERE DRAWN AND INFECTION WAS RULED OUT. (B)(6) 2014 OFFICE NOTES INDICATE THE PATIENT REPORTS FEELINGS OF CONTINUED STIFFNESS AND PAIN ANTERIORLY. (B)(6) 2014 OFFICE NOTES REVEAL THE PATIENTS PAIN IS SUSPECTED TO BE DUE TO LIGAMENTOUS INSTABILITY. (B)(6) 2015 REVISION NOTES INDICATE THE PATIENT RECEIVED A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO FAILED LEFT TOTAL KNEE REPLACEMENT. INDICATIONS REVEAL THE PATIENT WAS EXPERIENCING PAIN SECONDARY TO LIGAMENTOUS INSTABILITY, HE PRESENTED FOR ELECTIVE REVISION SURGERY. THIS PROCEDURE WAS COMPLETED WITHOUT COMPLICATION NOTED BY THE SURGEON. PLEASE NOTE, A COMPETI

  Patient problems: Adhesion(s); Edema; Joint Laxity; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9491740 ↗
• InjuryDec 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  COMPLAINT DESCRIPTION: DER STATED THAT THE PATIENT HAS 59 BMI, TOOK OUT A SIZE 5 CR ATTUNE FEMUR, SIZE 3 FIXED BEARING TIBIA. DON'T HAVE ACCESS TO ANY OTHER INFORMATION OR LOT NUMBERS. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. 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) 2017, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND ELEVATED WITH A SIMPLE OSTEOTOME WITH MINIMAL DIFFICULTY. HE REPORTED NO CONCERNS REGARDING THE FEMORAL COMPONENT, AND IT WAS REVISED. THE SURGEON DID NO COMMENT ON THE PATELLA, AND IT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED. DOI: (B)(6) 2015. DOR: (B)(6) 2017. (RT KNEE).

  Patient problems: No Code Available

  MAUDE report 9474289 ↗
• InjuryDec 3, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. 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. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS GROSSLY LOOSE AT THE IMPLANT TO CEMENT INTERFACE, AND EASILY REMOVED WITH JUST FINGER PRESSURE. HE NOTED THE FEMORAL COMPONENT WAS STABLE AND NOT REVISED. THE PATELLAR COMPONENT WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND DEPUY CEMENT X 2. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2015. DOR: (B)(6) 2018, (LT KNEE).

  Patient problems: No Code Available

  MAUDE report 9401677 ↗
• InjuryOct 28, 2019Loss 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

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 03 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. 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) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON INDICATED THE PATELLA WAS CLEANED AND THE PATELLAR BUTTON WAS NOT FOUND, AND WAS REVISED. HE OFFERED NO COMPLAINTS REGARDING THE FEMORAL COMPONENT, THOUGH IT WAS REVISED. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS FRANKLY LOOSE, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2016 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9246073 ↗
• InjuryJul 2, 2019Loss 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. DEPUY CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8752879 ↗
• InjuryJun 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2009; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8682298 ↗
• InjuryMar 27, 2019Loss 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. DEPUY CEMENT WAS USED. IT WAS REPORTED THAT THE TIBIA HAD SUBSIDED AND THAT THERE WAS SOME ANTERIOR BONE LOSS ON THE FEMUR. DOI: (B)(6) 2009; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8455544 ↗
• InjuryOct 3, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Code Available

  MAUDE report 7932188 ↗