NA 1294-53-235Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295026327), received between Jul 18, 2017 and Jul 11, 2025 — classified as 22 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• InjuryJul 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT WAS DUE TO BONE LOSS. CONVERTED TO A DFR. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22484371 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE REPLACEMENT. REVISING ATTUNE CR RP CEMENTED. CONVERTED TO PS RP CEMENTED. DOI: (B)(6) 2024. DOE: (B)(6) 2024. ADDITIONAL EVENT DESCRIPTION: PRIMARY (MEDACTA) KNEE HAD INFECTION. REVISED TO SROM HINGE. PERSISTENT INFECTION. RV WASHOUT OF SROM HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 19740643 ↗
• InjurySep 25, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS IDENTIFIED THAT ON AUG/2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST). DOI: (B)(6) 2002. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17807211 ↗
• InjuryJun 7, 2023Device Dislodged or Dislocated; No Apparent Adverse Event; Device Dislodged or Dislocated; No Apparent Adverse Event

  ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078533 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS UNSTABLE. THE SURGEON REMOVED THE FEMORAL COMPONENTS/POLY AND REPLACED FEMORAL COMPONENTS/POLY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15911055 ↗
• InjuryApr 25, 2022Fracture; Fracture

  NOILES FEMORAL IMPLANT BROKEN ON THE SLEEVE CONNECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Insufficient Information

  MAUDE report 14192365 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE OF MEDIAL AND LATERAL FEMORAL CONDLYLES: ABNORMAL RADIOGRAPHIC EVALUATION - LIKELY FEMORAL COMPONENT LOOSENING (UNCONFIRMED), WITH FRACTURE OF THE MEDIAL AND LATERAL CONDYLES, AND INSTABILITY EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF REVISION: (B)(6) 2017 (ALL COMPONENTS). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION OF THE FEMORAL AND INSERT COMPONENTS OCCURRED ON (B)(6) 2021.

  Patient problems: Fall; Joint Laxity; Limb Fracture; Pain; Swelling/ Edema

  MAUDE report 12415381 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL RIGHT TOTAL KNEE WITH CREPITANS, ADHESIONS EVENT IS SERIOUS AND IS CONSIDERED. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2010 (COMPETITOR KNEE SYSTEM). DATE OF REVISION #1: (B)(6) 2010 (REVISION OF COMPETITOR FEMUR, TIBIAL TRAY, INSERT - COMPETITOR PATELLA RETAINED). DATE OF EVENT (ONSET): (B)(6) 2013. (RIGHT KNEE). TREATMENT: SURGICAL ARTHROTOMY WITH EXCISION OF SCAR TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12363725 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE SEVENTH REVISION FOR THIS PATIENT. PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 ¿DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168103 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE TENTH REVISION FOR THIS PATIENT; PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12167997 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11687322 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FOR AN EVALUATION DUE TO RIGHT KNEE PAIN, SWELLING, SYNOVITIS, AND WARMTH. THE PHYSICIAN NOTED THE ASPIRATION OF 10 ML OF CLOUDY SLIGHTLY BROWNISH FLUID. THE PHYSICIAN INDICATED THE FLUID WOULD BE SENT OFF FOR CULTURES AND CELL COUNT. IT WAS ALSO NOTED THE PATIENT WOULD HAVE BLOOD WORK COMPLETED. THE PHYSICIAN INDICATED THE PATIENT WAS ON ORAL SUPPRESSION WITH DOXYCYCLINE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516499 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS REVISION DUE TO LOOSENING, INFECTION AND FRACTURE (LOOSENING AND FRACTURE ARE UNSPECIFIED). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10726954 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL TKA WAS AN INTERMEDICS DONE IN (B)(6) CITY.

  Patient problems: Adhesion(s); Discomfort; Edema; No Code Available; Pain

  MAUDE report 10646437 ↗
• InjurySep 29, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, EFFUSION, PAIN, DISCOMFORT, FEMORAL COMPONENT MIGRATION AND LOOSENING AT AN UNKNOWN INTERFACE, TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE, AND NO INGROWTH OF THE TIBIAL OR FEMORAL SLEEVES. THE UNKNOWN MANUFACTURER PATELLAR COMPONENT WAS RETAINED. ALL OTHER COMPONENTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 10600363 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2015 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, STIFFNESS AND HARDWARE FAILURE. UPON ENTERING THE JOINT, SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE BOLT WAS FOUND BROKEN AND HAD FALLEN OUT OF THE INTRACONDULAR NOTCH. THE BROKEN PORTION OF THE BOLT WAS STILL IN THE SLEEVE. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE. FEMORAL COMPONENTS AND INSERT WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRODUCTS IMPLANTED AT THIS REVISION ARE LOCATED ON PAGE 13-15. DOI: (B)(6) 2013. DOR: (B)(6) 2015. RIGHT KNEE.

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

  MAUDE report 10542086 ↗
• InjurySep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT KNEE REVISION TO ADDRESS IMPLANT LOOSENING AND IMPLANT FRACTURE DATE OF IMPLANTATION: UNK/UNK/1992, DATE OF REVISION #1: (B)(6) 2016 (INSERT, PATELLA), DATE OF REVISION #2: (B)(6) 2016 (FEMUR, TIBIAL BASE PLATE, INSERT), DATE OF REVISION #3: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF FEMUR CONSTRUCT, HINGED TIBIAL INSERT, AND TIBIA CONSTRUCT IMPLANTS.

  Patient problems: No Code Available; Pain

  MAUDE report 10487953 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE IMPLANTATION DATE OF THE RIGHT KNEE WAS (B)(6) 2019.

  Patient problems: Edema; Erythema; Injury; No Code Available; Not Applicable; Pain

  MAUDE report 10283391 ↗
• InjuryMar 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9832648 ↗
• 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 7741946 ↗
• InjuryJan 30, 2018Fracture; Fracture

  DR (B)(6) PRIVATE (B)(6) 2018: PRIMARY (B)(6) 2012; THIS IS NOT THE FIRST REVISION, PATIENT PRESENTED WITH KNEE PAIN. UPON OPENING THE KNEE THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE. THE FEMORAL BOLT WAS FOUND TO BE BROKEN AND WAS LOOSE IN THE KNEE. THE FEMORAL ADAPTER WAS ALSO FOUND BE BROKEN WITH THE VAGUS ANGLE CORRECTION RING OF THE ADAPTER FOUND LOOSE IN THE POSTERIOR PART OF THE KNEE. THE REMAINDER OF THE FEMORAL ADAPTER WAS STUCK IN THE FEMORAL SLEEVE AND COULD NOT BE REMOVED. THE WELL FIXED FEMORAL SLEEVE AND STEM WAS REMOVED. THE MBT REVISION TIBIA, SLEEVE AND TIBIA STEM WAS LEFT IN SITU NORTH AND APPEARED TO BE WELL FIXED. A NEW SIGMA TC3 SIZE 5 FEMUR AND LARGER SLEEVE AND NEW STEM WAS INSERTED. MALE PATIENT; (B)(6) YEARS OLD, (B)(6), 179CM AND (B)(6) KG. UNKNOWN_JRN: 1 X TC3 FEMUR. DOI: MAY 08,2012; DOR: JAN 05,2018; UNKNOWN AFFECTED SIDE NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 7227096 ↗
• InjuryJul 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES THAT THE PATIENT WAS REVISED TO ADDRESS SUSPECTED INFECTION. THE EVENT HAS A REMOTE POSSIBILITY OF BEING DEVICE RELATED AND IS DEFINITELY NOT PROCEDURE RELATED. UPDATE 6-21-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. OFFICE NOTES (B)(6) 2017 INDICATE THE PATIENT HAS BEEN EXPERIENCING SIGNIFICANT PAIN. RADIOLOGY REPORTS INDICATE TIBIAL SUBSIDENCE WITH LUCENCY AROUND THE ENTIRE TIBIAL COMPONENT. THERE IS ALSO LUCENCY BETWEEN THE CEMENT AND BONE INTERFACE ON THE FEMORAL COMPONENT, BUT NO INDICATION OF GROSS FEMORAL FAILURE. CLINICAL IMPRESSION: FAILED RIGHT TOTAL KNEE ARTHROPLASTY, SUSPECTED INFECTION. REVISION NOTES (B)(6) 2017: THE PATIENT RIGHT KNEE HAS BEEN BOTHERSOME FOR MANY YEARS WITH EVIDENCE OF LOOSENING OF THE TIBIAL COMPONENTS. DUE TO HIS HISTORY OF LEFT KNEE INFECTION IT WAS THOUGHT THERE COULD BE AN OCCULT CHRONIC INFECTION IN THE RIGHT KNEE CAUSING LOOSENING VS ASEPTIC LOOSENING. DUE TO THIS AND THE PATIENT'S SIGNIFICANT SYMPTOMS WITH CHRONIC EFFUSION AND CHRONIC PAIN, LOOSENING OF THE COMPONENTS RADIOGRAPHICALLY, IT WAS FELT EXPLORATION WITH REVISION WAS NEEDED. AT REVISION, THE SURGEON NOTED THERE WAS CLEAR FLUID WITHIN THE JOINT. THERE WAS METALLOSIS

  Patient problems: Foreign Body Reaction

  MAUDE report 6721390 ↗