NA 1294-54-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295026402), received between Mar 19, 2018 and Jul 30, 2025 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE SIGMA FEMORAL COMPONENT, FEMORAL SLEEVE, FEMORAL STEM, INSERT, TIBIAL TRAY, TIBIAL SLEEVE, AND TIBIAL STEM WERE REVISED FOR INFECTION. THE INSERT SHOWED MODERATE YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 22666256 ↗
• InjuryMar 11, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS REVISION OF TIBIAL CONSTRUCT AS THERE WAS NO IN-GROWTH BETWEEN THE SLEEVE AND BONE AND TIBIAL STEM WAS IMPINGING ON THE TIBIAL INTRAMEDULLARY CORTEX. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Tissue Injury

  MAUDE report 21575822 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION OF RIGHT KNEE. DOI: (B)(6) 2020, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20439998 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PROGRESSIVE PAIN AND RECURRENT HEMARTHROSIS RIGHT KNEE. BONE SCAN IMPLIED COMPONENTS MAY BE LOOSE. THEY WERE NOT. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19221271 ↗
• InjuryFeb 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT TOTAL KNEE. IMPLANTED DFR ON (B)(6) 2023 AND A POLY EXCHANGE ON (B)(6) 2023. PATIENT CAME INFECTED SO THEY EXPLANTED ALL IMPLANTS AND IMPLANTED A CEMENT SPACER USING ANTIBIOTIC SPACER AND EX-FIX RODS AND CONNECTOR. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 18774985 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18655315 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TIBIA. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 18138724 ↗
• InjurySep 20, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST). DOI: (B)(6) 2013; DOR: UNKNOWN; LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17781277 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A LCS KNEE SOME TIME AGO (NO DETAILS AVAILABLE OF INITIAL OPERATION. BEING REVISED TO A 1ST STAGE SPACER FOR INFECTION. NO FURTHER DETAILS AVAILABLE. IF OTHER, DESCRIBE INFECTION., IF OTHER, DESCRIBE 1ST STAGE REVISION TO TEMPORARY SPACER - INFECTION, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE REVISION SURGERY, OTHER INFORMATION N/A, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF -NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDI

  Patient problems: Unspecified Infection

  MAUDE report 15940094 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED DUE TO INSTABILITY AND ANTERIOR KNEE PAIN. SURGEON BELIEVES THE JOINT LINE WAS RAISED TOO MUCH RESULTING IN PATELLA BAJA. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP-01585465: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01585466: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01585467: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01585468: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01585469: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15925635 ↗
• MalfunctionJul 28, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A CASE ITEM WOULDN¿T IMPACT ONTO THE TIBIA. IT COULD EASILY BE LIFTED OFF BY HAND. WE HAD TO OPEN THE 29 SLEEVE CEMENTED OPTION WHICH IMPACTED EASILY ONTO THE TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122036 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED A BROKEN TIBIA AND NEEDED TO BE REVISED. DOI: (B)(6) 2014. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14676949 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE TIBIAL TRAY AT THE BONE TO CEMENT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. IMPLANTS WERE REMOVED AND INSERTION OF ANTIBIOTIC SPACER WAS PERFORMED. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14103979 ↗
• InjuryMar 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED LEFT KNEE. EXTRACTION OF COMPONENTS AND INSERTION OF ANTIBIOTIC SPACER WERE DONE. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13925423 ↗
• InjuryNov 7, 2021Osseointegration Problem; Osseointegration Problem

  TODAY A FULL NOILES CONSTRUCT WAS REVISED. THE REASON FOR THE REVISION WAS FOR ASEPTIC LOOSENING OF THE EXISTING IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2021. UNKNOWN SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12758563 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF TOTAL LEFT KNEE REPLACEMENT ON SEPSIS AND LOOSENING. FRACTURE / LOOSENING OF THE FEMORAL BOLT SCREW. CONSEQUENCE ON THE PATIENT: PAIN +++, NO DEBRIS, DISPLACEMENT OF THE FEMUR. DOI: (B)(6) 2019, DOR: UNKNOWN, LEFT KNEE.

  Patient problems: Pain; Sepsis

  MAUDE report 12357958 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FRACTURE BELOW THE TIBIA IMPLANT AND LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS REPORTED THAT THE TC3 AND MBT TRAY COMPONENTS WERE EXPLANTED, THE FRACTURE WAS REDUCED AND PLATED BY ANOTHER SURGEON. AN ATTUNE REVISION CONSTRUCT WAS IMPLANTED IN PLACE. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) , 2021 RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12127539 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND ALL IMPLANTS WERE REMOVED. THE PATIENT HAS MULTIPLE HEALTH ISSUES INCLUDING CANCER. THE PATIENT BEGAN TO HAVE AN ISSUE WITH THE KNEE APPROXIMATELY 3 MONTHS AGO AND BY THE TIME HE CAME IN, HE WAS GROSSLY INFECTED WITH A DRAINING SINUS. A STATIC SPACER WAS PLACED AFTER THOROUGH I&D. DOI: (B)(6) 2013. DOR: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 11117726 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF A SIGMA TC3 REVISION KNEE PROSTHESIS FOR INFECTION.

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

  MAUDE report 11091449 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS, DEVELOPED SEVERE HO AND COULD NOT STRAIGHTEN HER LEG. A THOROUGH DEBRIDEMENT TO INCLUDE ALL HO AND ALL IMPLANTS WERE REMOVED THEN REPLACED. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); Extraskeletal ossification; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10262434 ↗
• InjuryJun 30, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. UNIVERSAL STEM WAS FRACTURED AT THE JUNCTION WITH THE MBT REVISION TRAY PATIENT STATUS/ OUTCOME / CONSEQUENCES, YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.) REVISION KNEE SURGERY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IF YES, DESCRIBE, REVISION KNEE SURGERY, IS THE PATIENT PART OF A CLINICAL STUDY, UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Code Available

  MAUDE report 10215359 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED. ALL REVISION COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10149197 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DISTAL FEMUR FRACTURE, FLEXION INSTABILITY AND TIBIAL LOOSENING AT THE BONE TO CEMENT INTERFACE DUE TO FALL. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT HAD A PRIOR RIGHT KNEE REVISION DONE SOMETIME WITHIN THE LAST 10 YEARS IN POWAY, CA FOR TIBIAL LOOSENING. THE SURGEON TOLD THE SALES REP THAT FROM LOOKING AT THE X-RAY HIS PLAN WAS TO NAIL THE FEMUR THRU THE SIGMA CR FEMUR. HE ALSO SAID THAT HE BELIEVES THE TIBIAL COMPONENT ALSO BECAME LOOSE AFTER THE FALL, SO HE WANTED TO REVISION THE TIBIA. HE SAID THE PATIENT NEVER COMPLAINED OF PAIN OR INSTABILITY BEFORE THE FALL, EVEN THOUGH UNDER HIS EXAM, THE PATIENT HAD A LOT OF FLEXION INSTABILITY. HE FELT LIKE HE NEEDED TO ADD THICKNESS TO THE ALREADY THICK TRAY THE PATIENT CURRENTLY HAD IN. THE SURGEON IN CALIFORNIA, DIDN'T USE A STEM WITH HIS REVISION TIBIA. THE SURGEON NAILED THE FEMUR, THEN REMOVED THE LOOSE TIBIAL COMPONENT WITH EASE. HE ENDED UP USING THE NEXT SIZE TIBIAL SLEEVE (37MM), PUTTING IN A 115X14 PRESSFIT STEM, AND WENT WITH THE 25MM THICK TRAY AND A 10MM INSERT. HE WAS HAPPY WITH THE STABILITY AND WITH HOW THE FRACTURE WAS NAILED. DOI: LAST 10 YEARS; DOR:

  Patient problems: No Code Available; Pain

  MAUDE report 10030814 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PROXIMAL TIBIA FRACTURE WHICH CAUSED THE TRAY TO COLLAPSE. THE SIZE 4 MBT REV TRAY, 29MM SLEEVE AND 75X14 STEM WERE REMOVED AND LONGER STEM REV TRAY WERE PLACED. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9916429 ↗
• InjuryDec 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON OPENING THE KNEE THE TIBIAL COMPONENTS WERE SOMEWHAT LOOSE AND PATIENT WAS EXPERIENCING PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 9488977 ↗