NA 1294-54-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295026433), received between Jun 26, 2017 and May 5, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT PRESENTED AT EMERGENCY ROOM (ER) WITH LOOSE TIBIAL COMPONENT. TIBIAL COMPONENT WAS REMOVED AND REVISED WITHOUT DELAY OR HARM NOTED. IT WAS STATED THAT TIBIAL SLEEVE AND STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2013, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25086182 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER IN (B)(6) 2025 WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. NO INFORMATION WAS AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. NO INFORMATION AVAILABLE WITH REGARD TO PRODUCTS EXPLANTED ON (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND P

  Patient problems: Unspecified Infection

  MAUDE report 21883192 ↗
• InjuryOct 30, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THE INFECTION CONFIRMED? WAS IT THE MAIN REASON FOR THE REVISION? THIS WAS NOT OFFICIALLY CONFIRMED TO ME. I HAVE NOT HAD ANY WORD. THE IMPLANTS WERE ALSO LOOSENING SO WERE REVISED DUE TO THIS.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 20567780 ↗
• InjurySep 17, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED, DUE TO ASEPTIC LOOSENING AT UNKNOWN INTERFACE. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20235483 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR AN INFECTED LEFT HINGE KNEE. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED. THERE WERE NO SURGICAL DELAYS, DEFICIENCIES OR BROKEN INSTRUMENTS. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17135041 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT KNEE. ALL IMPLANTS WERE REMOVED. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16862224 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT A METAL ALLERGY. DOR: (B)(6) 2020.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14021804 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRA-OP EVENT OF SIGNIFICANT BLEEDING AT THE POSTEROLATERAL SIDE FROM THE POPLITEAL ARTERY AND THIS BLEEDING WAS STOPPED BY PACKING AND THE USE OF VASCULAR CLIPS, TOTAL BLOOD LOSS WAS 500 ML.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13558740 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPEAT STAGE 2 INFECTION. DOI: (B)(6) 2014; DOR: (B)(6) 2014. THIS COMPLAINT IS LINKED TO (B)(4). IT WAS CREATED TO CAPTURE THE EVENT THAT WAS INDICATED ON NOTE (B)(4).

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Scar Tissue; Wound Dehiscence

  MAUDE report 13548838 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 12517240 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED FOR COMPLAINTS OF PAIN WITH SUSPECTED INFECTION, NOT BEING CONFIRMED INTRAOPERATIVELY.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 12180265 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Muscle/Tendon Damage

  MAUDE report 11682086 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO END OF STEM PAIN. THE SURGEON REVISED THE ENTIRE CONSTRUCT TO A COMPETITIVE COMPANY. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11462619 ↗
• InjuryJun 29, 2020Malposition of Device; Malposition of Device

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF BOTH FEMORAL AND TIBIAL COMPONENTS: ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Bone Fracture(s); Injury; Muscular Rigidity; No Code Available; Pain; Swelling; Synovitis

  MAUDE report 10207363 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT KNEE REVISION. THE SURGEON REPORTED A STRESS CRACK OF THE MEDIAL TIBIAL PLATEAU WITH PLACEMENT OF THE SLEEVE COMPONENT, NO FURTHER FIXATION WAS DEEMED REQUIRED. DOE: (B)(6) 2017 (RIGHT KNEE).

  Patient problems: Bone Fracture(s)

  MAUDE report 9167475 ↗
• InjuryJun 24, 2019Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  REVISION TKR; REVISION OF PREVIOUSLY REVISED TIBIAL COMPONENT FOR ANTERIOR TIBIAL PAIN. TIBIAL COMPONENTS WERE REMOVED AND IT WAS NOTICED THAT VERY LITTLE BONY ON-GROWTH WAS PRESENT IN THE ANTERIOR SLEEVE. SURGEON CURIOUS IF TAPER BETWEEN SLEEVE AND TRAY WAS DAMAGE AND A CAUSE OF MICROMOTION? SAME SLEEVE HAD BEEN UTILIZED IN PREVIOUS REVISIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain

  MAUDE report 8727388 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT LOWER EXTREMITY SUPERFICIAL THROMBOSIS AND CELLULITIS - REDNESS AND SWELLING. ONSET OCCURRED A FEW DAYS AFTER PRIMARY IMPLANT SURGERY. DOI: (B)(6) 2012, LEFT KNEE.

  Patient problems: Cellulitis; Swelling; Thrombosis

  MAUDE report 8654009 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT LEFT ARTHROSCOPY AND DEBRIDEMENT FOR EXCESSIVE SCARRING, PAIN AND DECREASED ROM TO THE LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Scarring

  MAUDE report 8539388 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE (B)(6) 2019: ON (B)(6) 2014, 3 DAYS AFTER LEFT TKA REVISION, PATIENT DEVELOPED PULMONARY EDEMA AND CONGESTIVE HEART FAILURE WITH POSSIBLE MI. HE UNDERWENT A CABG X 5 FOR 3 VESSEL CARDIAC DISEASE ON (B)(6) 2014. PATIENT DEVELOPED BILATERAL PLEURAL EFFUSIONS AND INFECTION AFTER CABG REQUIRING STERNAL WOUND VAC AND IV ANTIBIOTIC ON (B)(6) 2014. DOI: (B)(6) 2014 DOE: (B)(6) 2014.

  Patient problems: Heart Failure; Myocardial Infarction; Pleural Effusion; Pulmonary Edema; Unspecified Infection

  MAUDE report 8537393 ↗
• InjuryFeb 20, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED ON (B)(6) 2019 TO ADDRESS PAIN AND LOOSENING OF THE MBT REVISION COMPONENTS AT THE BONE TO CEMENT AND BONE TO IMPLANT INTERFACE IN THE RIGHT KNEE. DEPUY CEMENT WAS USED. ALL COMPONENTS OF TC3 MBT REVISION WERE REMOVED. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8353493 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE REVISION OF KNEE ARTHROPLASTY. PATIENT CONSEQUENCE?: UNKNOWN. PATIENT CONSEQUENCE DESCRIPTION: PAIN AND DIFFICULT TO WALK. ACTION TAKEN FOR PROCEDURE: CULTURES TAKEN, IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Pain

  MAUDE report 7741919 ↗
• InjuryJun 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT HAD PRIMARY TKA ON BOTH SIDES 2 YEARS AGO BUT HAS EXPERIENCED CHRONIC EFFUSIONS ON BOTH KNEES SINCE PRIMARY SURGERY. PATIENT RTKA WAS REVISED ON (B)(6) 2017. HE DID PERFECTLY WELL FOR 8 DAYS ON THE 9TH DAY HE EXPERIENCED ACUTE SWELLING AND APPARENT INFECTION. SURGEON ELECTED TO I&D WITH POLY EXCHANGE ON (B)(6) 2017. HE ELECTED TO REMOVE ALL IMPLANTS ON (B)(6) 2017 AND IMPLANT ANTIBIOTIC BEADS, SPACER AND LOOSELY CEMENTED PRIMARY CR ATTUNE FEMUR, LOOSELY CEMENTED PSRP INSERT WITH TOP POST REMOVED. SURGEON IS AWARE THIS IS OFF LABEL BUT FELT IT WAS THE BEST INTEREST OF THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 6666608 ↗