NA 5450-31-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10603295174264), received between Jul 18, 2017 and Jan 21, 2026 — classified as 2 deaths, 162 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (94 reports).

1 other recall cover devices cleared under the same FDA submission (K023103, K033382, K033563, K041656, K053002, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD ASEPTIC TIBIAL LOOSENING. FEMUR, TIBIA AND INSERT WERE REMOVED. NO PATIENT INJURY OR DELAY. IT WAS STATED THAT THE TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS BONE TO CEMENT. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24133660 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INCREASED PAIN, REDNESS, AND MILD ERYTHEMA. IV ANTIBIOTICS WAS STARTED FOR TREATMENT OF POSSIBLE CELLULITIS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cellulitis; Erythema; Pain

  MAUDE report 21996071 ↗
• InjuryDec 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF THE PAIN. THE SURGEON DID A BONE SCAN AND THOUGHT FEMORAL AND POSSIBLE TIBIAL COMPONENT WERE LOOSE. IN THE SURGERY THE FEMORAL COMPONENT WAS LOOSE FROM THE CEMENT TO THE BONE INTERFACE. THE SURGEON DECIDED TO REMOVE THE TIBIAL COMPONENT AS WELL TO BE ABLE TO REVISE WITH ATTUNE CRS IMPLANTS. NOTHING WAS MENTIONED AS A PROBLEM WITH COMPONENTS SINCE CEMENT WAS STILL ON BOTH, BUT THE BOND FROM CEMENT TO BONE WAS LOOSE. THE SURGEON THOUGHT THE PATIENT MAY HAVE SUFFERED A FALL AND LOOSENED HIS FEMORAL COMPONENT. DEPUY CMW 1 CEMENT WAS USED IN THE SURGERY. THE HOSPITAL PURCHASES THEIR OWN CEMENT SO THE LOT NUMBERS WERE UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 20820930 ↗
• InjuryDec 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF THE PAIN. THE SURGEON DID A BONE SCAN AND THOUGHT FEMORAL AND POSSIBLE TIBIAL COMPONENT WERE LOOSE. IN THE SURGERY THE FEMORAL COMPONENT WAS LOOSE FROM THE CEMENT TO THE BONE INTERFACE. THE SURGEON DECIDED TO REMOVE THE TIBIAL COMPONENT AS WELL TO BE ABLE TO REVISE WITH ATTUNE CRS IMPLANTS. NOTHING WAS MENTIONED AS A PROBLEM WITH COMPONENTS SINCE CEMENT WAS STILL ON BOTH, BUT THE BOND FROM CEMENT TO BONE WAS LOOSE. THE SURGEON THOUGHT THE PATIENT MAY HAVE SUFFERED A FALL AND LOOSENED HIS FEMORAL COMPONENT. DEPUY CMW 1 CEMENT WAS USED IN THE SURGERY. THE HOSPITAL PURCHASES THEIR OWN CEMENT SO THE LOT NUMBERS WERE UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 20820702 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED POST TKA FOR INFECTION. SURGEON CHOSES TO PERFORM A ONE STAGE REVISION TKA WITH A DUAL SET UP AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. ALL WELL FIXED WERE COMPONENTS REMOVED AND A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED PRIOR TO PREPPING FOR NEW COMPONENTS. A PORTION OF THE ANTERIOR TIBIA CAME OFF WHEN THE TIBIA COMPONENT WAS REMOVED HOWEVER THE SLEEVE HAD GOOD FIXATION WHEN PREPARED. NO DELAY WAS EXPERIENCED. THERE WAS NO LOOSENING BUT DEPUY CEMENT HAS BEEN USED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19361822 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED POST TKA FOR INFECTION. SURGEON CHOSES TO PERFORM A ONE STAGE REVISION TKA WITH A DUAL SET UP AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. ALL WELL FIXED WERE COMPONENTS REMOVED AND A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED PRIOR TO PREPPING FOR NEW COMPONENTS. A PORTION OF THE THE ANTERIOR TIBIA CAME OFF WHEN THE TIBIA COMPONENT WAS REMOVED HOWEVER THE SLEEVE HAD GOOD FIXATION WHEN PREPARED. NO DELAY WAS EXPERIENCED. THERE WAS NO LOOSENING BUT DEPUY CEMENT HAS BEEN USED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19361821 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REFERRED POST INFECTION TKA. PATEINT WAS ALSO WASHED OUT ON ON (B)(6) 2024 AND INSERT WAS EXCHANGED. UNFORTUNATELY THIS TREATMENT WAS UNSUCCESSFUL AND A COMPLETE REMOVAL OF HARDWARE WAS REQUIRED. SURGEON CHOSE A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS DUE TO CONSIDERABLE CONCERNS WITH THE PATIENTS SKIN AND ABILITY TO CLOSE HER. THERE WAS NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19279394 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REFERRED POST INFECTION TKA. PATEINT WAS ALSO WASHED OUT ON ON (B)(6) 2024 AND INSERT WAS EXCHANGED. UNFORTUNATELY THIS TREATMENT WAS UNSUCCESSFUL AND A COMPLETE REMOVAL OF HARDWARE WAS REQUIRED. SURGEON CHOSE A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS DUE TO CONSIDERABLE CONCERNS WITH THE PATIENTS SKIN AND ABILITY TO CLOSE HER. THERE WAS NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19279383 ↗
• InjuryApr 19, 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 SCAR TISSUE ON QUAD TENDON. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2024, (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Adhesion(s)

  MAUDE report 19146730 ↗
• InjuryJan 31, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SURGEON SAID THE PATIENT COMPLAINED OF PAIN MONTHS AFTER THEIR PRIMARY KNEE SURGERY. HE THOUGHT THEY MAY HAVE AESEPTIC LOOSENING SINCE THEY DID NOT SHOW ANY SIGNS OF INFECTION. HE REMOVED ALL COMPONENTS AND WAITED ON CULTURES TO MAKE SURE THE PATIENT WAS NOT INFECTED AND REPLACED IMPLANTS WITH ATTUNE REVISION COMPONENTS. ALL COMPONENTS SEEMED TO BE CEMENTED ON WELL. BONE AND CEMENT WERE STILL ON THE FLAT PART OF THE TIBIAL TRAY. SALES REP DID NOT OBSERVE ANY CEMENT ON THE CONE OF THE TIBIAL COMPONENT. NO ONE MENTIONED THEIR BEING ANY PROBLEMS WITH OUR IMPLANTS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18613445 ↗
• InjuryJan 31, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SURGEON SAID THE PATIENT COMPLAINED OF PAIN MONTHS AFTER THEIR PRIMARY KNEE SURGERY. HE THOUGHT THEY MAY HAVE AESEPTIC LOOSENING SINCE THEY DID NOT SHOW ANY SIGNS OF INFECTION. HE REMOVED ALL COMPONENTS AND WAITED ON CULTURES TO MAKE SURE THE PATIENT WAS NOT INFECTED AND REPLACED IMPLANTS WITH ATTUNE REVISION COMPONENTS. ALL COMPONENTS SEEMED TO BE CEMENTED ON WELL. BONE AND CEMENT WERE STILL ON THE FLAT PART OF THE TIBIAL TRAY. SALES REP DID NOT OBSERVE ANY CEMENT ON THE CONE OF THE TIBIAL COMPONENT. NO ONE MENTIONED THEIR BEING ANY PROBLEMS WITH OUR IMPLANTS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18613440 ↗
• InjuryJan 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION FOR PAIN AND INSTABILITY. THE TIBIAL TRAY HAD BECOME LOOSE AT BOTH INTERFACES AND SUBSIDED. SCARRING, SCLEROTIC BONE, SYNOVITIS, OSTEOPHYTES AND ERODED BONE MEDIALLY ON THE TIBIA WAS IDENTIFIED. DOI: (B)(6) 2013; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 18436515 ↗
• InjuryJan 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION FOR PAIN AND INSTABILITY. THE TIBIAL TRAY HAD BECOME LOOSE AT BOTH INTERFACES AND SUBSIDED. SCARRING, SCLEROTIC BONE, SYNOVITIS, OSTEOPHYTES AND ERODED BONE MEDIALLY ON THE TIBIA WAS IDENTIFIED. DOI:(B)(6) 2013. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 18436495 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR NAUSEA AND VOMITING AND RE-ADMITTED TO HOSPITAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: MEDICAL WORKUP RESULTING IN DX OF SHOWER EMBOLI AND TREATED WITH ELIQUIS.

  Patient problems: Embolism/Embolus; Nausea; Vomiting

  MAUDE report 18138972 ↗
• DeathNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE). TREATMENT: ADVERSE EVENT RESULTED IN DEATH.

  Patient problems: Pulmonary Embolism

  MAUDE report 18138917 ↗
• DeathNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR PE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE). TREATMENT: ADVERSE EVENT RESULTED IN DEATH.

  Patient problems: Pulmonary Embolism

  MAUDE report 18138916 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, MEDICAL RECORDS REPORTED THAT THE PATIENT UNDERGOES A STEROID INJECTION FOR RIGHT KNEE PAIN AND CREPITATION. DOI: ON (B)(6) 2012; DOE: UNKNOWN; RIGHT KNEE.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 17086060 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT COMPLAINS OF RIGHT KNEE PAIN. AN ASPIRATION IS DONE TO RULE OUT INFECTION. DOI: (B)(6) 2012. DOE: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17085645 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON BEHALF OF THE PATIENT: PATIENT SAID THAT HE HAD 2 SURGERIES THAT RESULTED IN KNEE REPLACEMENT INTO HIS LEGS. THE FIRST SURGERY HAPPENED IN 2021 HE SAID THAT WAS PERFECTLY FINE. SECOND SURGERY HAPPENED 3 MONTHS BACK HE FEEL PAIN. HE THINK THAT THE DOCTOR PUT IN INCORRECTLY WHICH IS SOMETHING WRONG WITH THE ITEM. IT WAS THE SAME DOCTOR THAT DID BOTH THE PROCEDURES. PATIENT SAID HE NO LONGER CAN WORK AND ALSO WALK, WALKS WITH THE CANE AND ALSO LOST HIS JOB.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 17001728 ↗
• InjuryApr 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT AND IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B(6) 2000. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16833219 ↗
• InjuryMar 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. . THE FEMUR WAS NOT LOOSE BUT AFTER STRIKING THE TIBIA FOUR OR FIVE TIMES IT CAME OUT. SURGEON DECIDED TO REMOVE THE FEMUR AS WELL AND REVISE BOTH SIDES SINCE PATIENT HAD SOFT BONE. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16548034 ↗
• InjuryMar 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. . THE FEMUR WAS NOT LOOSE BUT AFTER STRIKING THE TIBIA FOUR OR FIVE TIMES IT CAME OUT. SURGEON DECIDED TO REMOVE THE FEMUR AS WELL AND REVISE BOTH SIDES SINCE PATIENT HAD SOFT BONE. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16548024 ↗
• InjuryMar 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN AND A LACK OF MOTION, ASEPTIC LOOSENING OF THE TIBIA WAS SUSPECTED AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16547940 ↗
• MalfunctionMar 9, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE CEMENT HAD A CONTAMINATED PACKAGING. NO EFFECT TO PATIENT. THE SURGEON WAS PLANNING TO USE THE DEFECTIVE PACKAGE BUT WHEN THE NURSE OPENED THE BOX OF CEMENT, NOTICED THE PRODUCT COULD NOT BE CONSIDERED STERILE. THE PRODUCT WAS WASTED DUE TO A TEAR/HOLE IN THE PLASTIC PACKAGING, WHICH EXPOSED THE STERILE CEMENT. THE HOLE WAS LOCATED AT THE EDGE/END THAT WAS USED TO OPEN THE PACKAGE JUST BEFORE THE STERILE PART OF THE PRODUCT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512062 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16459729 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023103, K033382, K033563, K041656, K053002, 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