SMARTSET 5450-35-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 965 adverse event reports that list this exact device (DI 10603295174288), received between Jul 7, 2017 and Sep 18, 2026 — classified as 2 deaths, 939 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (772 reports).

1 other recall cover devices cleared under the same FDA submission (K023012, K033382, K033563, K053002, K053445, K061144, K081163); 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 25 most recent of 965 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823371 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24307980 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24307972 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. CEMENT MANUFACTURER WAS DEPUY SYNTHES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22293322 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. CEMENT MANUFACTURER WAS DEPUY SYNTHES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22293138 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. CEMENT MANUFACTURER WAS DEPUY SYNTHES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22293056 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. CEMENT MANUFACTURER WAS DEPUY SYNTHES. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22293012 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR:(B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS TH

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21987532 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS T

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21987388 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS T

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21987291 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS T

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 21987086 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD A FULL REVISION OF LEFT KNEE TO ADDRESS PAIN AND A POPPING SENSATION. DURING THE SURGERY THE PATIENT STATED THE SURGEON FOUND THAT THE TIBIAL BASE PLATE WAS LOOSE AND HAD POPPED RIGHT OUT. THE KNEE CAP (PATELLA) WAS ALSO OUT OF TRACK. DOI: (B)(6) 2016. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Pain; Unspecified Musculoskeletal problem

  MAUDE report 21986465 ↗
• InjuryMar 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2023. SINCE THAT TIME, THE PATIENT HAS EXPERIENCED THE FEELING OF THEIR GIVING OUT, SEVERAL FALLS, PAIN, AND FLUID BUILD UP. THE PATIENT HAD AN ASPIRATION DONE WHICH DRAINED FLUID WITH "DEBRIS". THE PATIENT ALSO REPORTS THAT A SURGEON DID XRAYS AND STATED THAT THE KNEE "HAS BEEN LOOSE". THE PATIENT IS SCHEDULED FOR REVISION ON (B)(6) 2025. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: RIGHT.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Fall; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21686363 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE REPLACEMENT USING ATTUNE IMPLANTS INCLUDING A PATELLA AND SMARTSET BONE CEMENT. ON (B)(6) 2018, SHE EXPERIENCED A NEW ONSET OF RIGHT KNEE PAIN AFTER DOING SOME HOUSE CLEANING. SHE STATES THERE IS A LOT OF CLICKING AND STIFFNESS AS WELL. PHYSICAL THERAPY IS ORDERED. ON (B)(6) 2024, THE PATIENT HAS A RIGHT KNEE BONE SCAN REVEALING SUSPECTED LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. ON (B)(6) 2024, THE PATIENT UNDERWENT A RIGHT KNEE REVISION. INTRAOPERATIVELY THERE WAS SCAR TISSUE, EXTENSIVE SYNOVITIS, AND THE TIBIAL COMPONENT WAS CONFIRMED TO BE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE FEMORAL COMPONENT WAS WELL FIXED. THE PATIENT WAS REVISED TO COMPETITOR IMPLANTS THOUGH THE PATELLA WAS LEFT IN SITU. DOI: (B)(6) 2018 DOR: (B)(6) 2024 RIGHT KNEE.

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

  MAUDE report 21228444 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANT SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21199975 ↗
• InjuryNov 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  DOI: (B)(6) 2015: MALE PATIENT RECEIVED AN ATTUNE RIGHT TKA TO TREAT OA. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2021: 67 YEAR-OLD MALE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON EXPRESSED A SMALL EFFUSION AND DEBRIDED SYNOVITIS. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 20673736 ↗
• InjuryNov 13, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  DOI: ON (B)(6) 2015: MALE PATIENT RECEIVED AN ATTUNE RIGHT TKA TO TREAT OA. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: ON (B)(6) 2021: 67-YEAR-OLD MALE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON EXPRESSED A SMALL EFFUSION AND DEBRIDED SYNOVITIS. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: ON (B)(6) 2015, DOR: ON (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 20673648 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017: PATIENT UNDERWENT A RIGHT TKA FOR DJD. DEPUY COMPONENTS PLACED WITH THE PATELLA RESURFACED. DEPUY CEMENT X2 WAS USED. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2018: PATIENT EXPERIENCED A "LOUD POP" AND PAIN. PATIENT UNDERWENT A REVISION FOR ASEPTIC LOOSENING. THE TIBIAL TRAY WAS FOUND TO BE GROSSLY LOOSE AND WAS DEBONDED FROM THE CEMENT MANTLE. THE TIBIAL INSERT AND FEMORAL COMPONENT WAS ALSO REMOVED WITH NO ALLEGATIONS. THE PATELLA WASN'T REVISED AND COMPETITOR COMPONENTS AND CEMENT WERE PLACED IN A REVISION. DOI: (B)(6) 2017, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20665856 ↗
• InjuryNov 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) 2017: PATIENT UNDERWENT A RIGHT TKA FOR DJD. DEPUY COMPONENTS PLACED WITH THE PATELLA RESURFACED. DEPUY CEMENT X2 WAS USED. NO COMPLICATIONS WERE NOTED. (B)(6) 2018: PATIENT EXPERIENCED A "LOUD POP" AND PAIN. PATIENT UNDERWENT A REVISION FOR ASEPTIC LOOSENING. THE TIBIAL TRAY WAS FOUND TO BE GROSSLY LOOSE AND WAS DEBONDED FROM THE CEMENT MANTLE. THE TIBIAL INSERT AND FEMORAL COMPONENT WAS ALSO REMOVED WITH NO ALLEGATIONS. THE PATELLA WASN'T REVISED AND COMPETITOR COMPONENTS AND CEMENT WERE PLACED IN A REVISION. DOI: (B)(6) 2017. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20664618 ↗
• InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO COMPLAINTS OF CHRONIC LEFT KNEE PAIN AND WAS EVALUATED TO HAVE AN END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2021, PATIENT UNDERWENT A TOTAL LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20659624 ↗
• InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN ATTUNE PRIMARY LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS ON (B)(6) 2016. DEPUY BONE CEMENT WAS USED. AS PART OF THE TREATMENT, PATIENT ALSO RECEIVED AUTOLOGOUS PLATELET RICH PLASMA WHICH WAS APPLIED TO THE DEEP PORTIONS OF THE PATIENT'S INCISION DURING WOUND CLOSURE TO SUPPORT WOUND HEALING. THE PATIENT HAD NO COMPLICATIONS. PATIENT'S LEFT TOTAL KNEE WAS REVISED ON (B)(6) 2024, TO ADDRESS ASEPTIC IMPLANT LOOSENING OF THE TIBIAL BASEPLATE WITH COMPLETE DEBONDING (CEMENT TO IMPLANT INTERFACE) AND CHRONIC PATELLAR TENDON RUPTURE. FEMUR, TIBIAL BASEPLATE, AND INSERT WERE EXPLANTED. PATELLA COMPONENT WAS WELL-FIXED AND RETAINED. PATELLA TENDON WAS REINFORCED WITH A TUBULARIZED MARLEX MESH BUNDLE. THERE WERE NO COMPLICATIONS. COMPETITOR REVISION FEMUR AND TIBIAL COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2024; LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20658194 ↗
• InjuryNov 11, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO COMPLAINTS OF CHRONIC LEFT KNEE PAIN AND WAS EVALUATED TO HAVE AN END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS ON (B)(6) 2021, PATIENT UNDERWENT A TOTAL LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT COMPETITOR CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION TIBIAL CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20656949 ↗
• InjuryNov 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 29 OCT 2024: IT WAS REPORTED ON (B)(6) 2015: 54-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. REVISION SURGERY OCCURRED (B)(6) 2019: 57-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT CEMENT TO IMPLANT INTERFACE WITH MIGRATION INTO VARUS AND EXTENSIVE TIBIAL BONE LOSS, AND REVISED. SURGEONS NOT THERE WAS A PARTIALLY HEALED TIBIAL CONDYLE FRACTURE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND THE PATELLA WAS RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

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

  MAUDE report 20622478 ↗
• InjuryNov 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 29 OCT 2024: IT WAS REPORTED ON (B)(6) 2015: 54-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. REVISION SURGERY OCCURRED (B)(6) 2019: 57-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT CEMENT TO IMPLANT INTERFACE WITH MIGRATION INTO VARUS AND EXTENSIVE TIBIAL BONE LOSS, AND REVISED. SURGEONS NOT THERE WAS A PARTIALLY HEALED TIBIAL CONDYLE FRACTURE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND THE PATELLA WAS RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

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

  MAUDE report 20622110 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: (B)(6) 2018: 60-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2022: 65-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY WAS LOOSE AT AN UNKNOWN INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED DUE TO FEMORAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND PATELLA. THE PATIENT RECEIVED AND UNKNOWN REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20621858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023012, K033382, K033563, K053002, K053445, K061144, K081163. 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