SMARTSET 3092-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295168324), received between Nov 29, 2018 and Nov 29, 2022 — classified as 23 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (22 reports).

1 other recall cover devices cleared under the same FDA submission (K023012, K033563); they may or may not involve this specific model.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT A SUCCESSFUL LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016 UTILIZING DEPUY IMPLANTS INCLUDING PATELLA AND CEMENT X2. PATIENT WAS LATER REVISED ON (B)(6) 2021 FOR SWELLING, PAIN, AND XRAYS SUGGESTIVE OF RADIOLUCENCIES UNDER THE MEDIAL TIBIAL PLATE. INTRAOPERATIVELY, THE SYNOVIUM WAS GRAY AND HYPERTROPHIC ¿CONSISTENT WITH CEMENT DEBRIS SYNOVITIS¿ BUT ¿NO SIGNIFICANT POLY WEAR.¿ THE TIBIAL PLATE WAS COMPLETELY DEBONDED FROM THE CEMENT. THERE WAS OSTEOLYSIS ALONG THE FEMORAL CONDYLE AND MEDIAL TIBIA. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL FIXED AND NOT REVISED. DOI: (B)(6) 2016. DOR: (B)(6) 2021. (TIBIAL TRAY AND INSERT - LEFT KNEE).

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 15876667 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS PAIN. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT, TIBIAL TRAY, FEMORAL COMPONENT, AND DEPUY CEMENT PRODUCT. THE PATELLA COMPONENT WAS RETAINED.

  Patient problems: Discomfort; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 13358501 ↗
• InjuryOct 12, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  RECORDS INDICATE THE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE ARTHROPLASTY. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 12616638 ↗
• InjuryMay 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. THE SURGEON FOUND THE KEELED GLENOID FLOATING AROUND INSIDE THE JOINT AND REMOVED IT. UPON EXAMINING THE OTHER IMPLANTS, IT WAS DETERMINED THAT THE PATIENT HAD A FUNCTIONING HEMI ARTHROPLASTY SO THE SURGEON LEFT ALL THE IMPLANTS AS THEY WERE ALL FIXED. DOI: (B)(6) 2015, DOR: (B)(6) 2021, LEFT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 11891557 ↗
• InjuryApr 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  TIBIAL LOOSENING CEMENT TO IMPLANT INTERFACED.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9982419 ↗
• InjuryJan 13, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS TIBIA DEBONDMENT. DOI: UNK; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: Cyst(s); Edema; No Code Available; Osteolysis; Pain

  MAUDE report 9583241 ↗
• InjuryJan 13, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION DUE TOP LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE AND PAIN. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL-FIXED AND RETAINED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED. DOI: (B)(6) 2016. DOR: (B)(6) 2018 (TIBIAL COMPONENTS).

  Patient problems: No Code Available; Pain

  MAUDE report 9580348 ↗
• InjuryJan 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT AND LOOSENING OF THE TIBIAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: 2-3 YEARS AGO. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9571747 ↗
• InjuryJan 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. 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, SYNOVITIS, SWELLING, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS LOOSE AND COMPLETELY DE-BONDED AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED A WELL-FIXED FEMORAL COMPONENT WHICH WAS NOT REVISE. THE SURGEON INDICATED THE PATELLA WAS WELL FIXED AND RETAINED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND DEPUY CEMENT X 1 DOI: (B)(6) 2016; DOR: (B)(6) 2018 (LT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9571268 ↗
• InjuryJan 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. 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) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SWELLING, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS COMPLETELY DE-BONDED WITH NO CEMENT ATTACHED TO THE TIBIAL COMPONENT. HE INDICATED THE MEDIAL CEMENT WAS LOOSE WITH OBVIOUS FIBROUS MATERIAL IN THE BONE CEMENT INTERFACE. HE DID NOT COMMENT ON THE FEMORAL COMPONENT, AND IT WAS RETAINED. THE SURGEON INDICATED THE PATELLA TRACKING WAS CENTRAL AND RETAINED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH ATTUNE TIBIAL REVISION SYSTEM AND DEPUY CEMENT X 2. DOI: (B)(6) 2016 DOR: (B)(6) 2019 (RT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9570815 ↗
• InjuryJan 9, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT AN UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9570126 ↗
• InjuryJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF THE LEFT KNEE SECONDARY TO PAIN, DECREASED RANGE OF MOTION AND SUSPECTED TIBIAL LOOSENING. INTRAOPERATIVELY, THE SURGEON DISCOVERED TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE AND MEDIAL TIBIAL OSTEOLYSIS. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL-FIXED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. DOI: (B)(6) 2016; DOR: (B)(6) 2018 (TIBIAL COMPONENTS).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9548687 ↗
• InjuryDec 6, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY. THE TIBIAL WAS FRACTURED DURING THE REVISION SURGERY. DOI: UNKNOWN: DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9431974 ↗
• InjuryDec 3, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SWELLING, MILD FLEXION INSTABILITY, AND PAIN. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY DE-BONDED AT THE CEMENT/IMPLANT INTERFACE, AND WELL-FIXED TO THE PROXIMAL TIBIA. HE DID NOT SPEAK TO THE STATE OF THE FEMORAL COMPONENT THOUGH IT WAS REVISED. THE SURGEON INDICATED THE PATELLAR COMPONENT WAS TRACKING CENTRAL AND WAS REVISED. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2019; (LT KNEE).

  Patient problems: Discomfort; Edema; No Code Available; Pain

  MAUDE report 9401086 ↗
• InjuryAug 30, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A SECOND LEFT KNEE REVISION DUE TO PAIN, SWELLING, SYNOVITIS AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED DURING THE FIRST REVISION OPERATION. DOI: (B)(6) 2015, TIBIAL TRAY AND FEMORAL COMPONENT. DOI: (B)(6) 2016, TIBIAL INSERT AND PATELLA COMPONENT. DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8952027 ↗
• InjuryAug 30, 2019Loss of or Failure to Bond; Loss of Osseointegration; Loss of or Failure to Bond; Loss of Osseointegration

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, DECREASED RANGE OF MOTION, SWELLING, INSTABILITY, AND PATELLA COMPONENT LOOSENING AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. THE DISCHARGE SUMMARY NOTED ACUTE BLOOD LOSS ANEMIA SECONDARY TO THE REVISION. THE TIBIAL INSERT AND PATELLA COMPONENT WERE THE ONLY PRODUCTS REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015, DOR: (B)(6) 2016, LEFT KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Swelling

  MAUDE report 8950052 ↗
• InjuryAug 27, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE SURGEON INDICATED THE PATIENT WILL UNDERGO A RIGHT KNEE REVISION DUE TO SUSPECTED TIBIAL TRAY LOOSENING WHEN THE PATIENT IS MEDICALLY CLEARED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016, DOR: UNKNOWN, RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; No Consequences Or Impact To Patient; Pain

  MAUDE report 8934903 ↗
• InjuryAug 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, EFFUSIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8928038 ↗
• InjuryJul 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AND THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8792700 ↗
• InjuryJul 15, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: 2 TO 3 YEARS AGO. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Discomfort; No Code Available; Pain; Swelling; Tissue Damage

  MAUDE report 8789014 ↗
• InjuryJul 9, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: 2-3 YEARS AGO, DOR: (B)(6) 2018, UNKNOWN SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8771080 ↗
• InjuryNov 29, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, LOSS OF MOTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8115184 ↗
• InjuryNov 29, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, LOSS OF MOTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Joint Disorder; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8115156 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023012, K033563. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2015 · Feb 11, 2015 · Terminated
  SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis