NA 1294-35-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295026044), received between Jul 19, 2018 and Jan 7, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE AND STABILITY. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PREVIOUS TRAUMATIC INJURY. THE PREVIOUS IMPLANTS WERE UPSIZED BECAUSE OF LOOSENING IN THE TIBIA AND FEMUR AND THE ACTUAL POLYETHYLENE WAS NOT WORN OUT. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23992718 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISING DUE TO NICKEL ALLERGY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18571020 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY. THEY HAD PAIN THROUGHOUT THEIR LEG, SO THE SURGEON REPLACED EVERYTHING WITH COMPETITOR IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18184831 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT TC3/MBT REVISION KNEE REVISED DUE TO INSTABILITY, PAIN, AND TIBIAL LOOSENING. PATIENT WAS REVISED TO TC3/MBT CONSTRUCT USING A THICK BASEPLATE AND CONSTRAINED POLY INSERT. THERE WERE NO NOTED COMPLAINTS OR DELAYS WITH THE PRODUCTS OR PROCEDURE. EXPLANTS ARE UNAVAILABLE FOR RETURN. SOME REFERENCE/LOT NUMBERS WERE NOT LEGIBLE DUE TO CEMENT COVERING AND DAMAGE DURING EXPLANTATION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16130379 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY DUE TO FALL AND A BONE SCAN WAS ORDERED IT WAS DETERMINED THAT THE FEMORAL COMPONENT WAS LOOSED AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. ALL THE COMPONENTS WERE REMOVED EXCEPT THE PATELLA. NEW REVISION COMPONENTS WERE IMPLANTED AND THE HAS A FULL RANGE OF MOTION FROM EXTENSION TO FLEXION. NO SURGICAL DELAY. DOI : (B)(6) 2018 DOR : (B)(6) 2021 RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12719713 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST STAGE REVISION CASE DUE TO INFECTION. REMOVAL OF OUR COMPONENTS. LPS DISTAL FEMUR + MBT THICK TRAY + POLY REMOVAL. PLEASE SEE PREVIOUS USAGE ATTACHED. THEY REPLACED THE COMPONENTS WITH A S&N FEMORAL NAIL COVERED WITH CEMENT/VANCOMYOCIN. 2ND STAGE OF REVISION WILL BE IN 3-6 MONTHS TIME TO GIVE TIME FOR BUG TO BE KILLED OFF. 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: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(6) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSE

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

  MAUDE report 12112528 ↗
• InjuryAug 26, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE PATIENT HAD A REVISION KNEE DONE PREVIOUSLY WITH TC3 AND MBT REVISION IMPLANTS. RECORDS ON THE PREVIOUS SURGERY WERE UNAVAILABLE. TIBIAL COMPONENT APPEARS LOOSE AND THE TIBIAL STEM HAS MIGRATED THROUGH THE LATERAL CORTEX DISTALLY. PLAN IS TO REMOVE THE TIBIAL COMPONENT AND REPLACE IT WITH A NEW TRAY WITH A LONGER STEM. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10455141 ↗
• MalfunctionSep 12, 2019Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth

  CLINICAL ADVERSE EVENT RECEIVED FOR GROSSLY LOOSE TIBIA, FEMUR IS INTACT AND WELL INGROWN: MIGRATION / LOOSENING - TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT IT IS RELATED TO PROCEDURE. DATE OF REVISION # 1: (B)(6) 2011. DATE OF REVISION # 2: (B)(6) 2012. DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9012424 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCING TIBIAL PAIN.

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

  MAUDE report 8415884 ↗
• InjuryDec 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION DUE TO LOOSENING.

  Patient problems: No Code Available

  MAUDE report 8187390 ↗
• InjuryDec 15, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 8167465 ↗
• InjuryNov 14, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY, SLEEVE AND STEM COMPONENT AT THE BONE TO CEMENT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8069761 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS TIBIAL TRAY SUBSIDENCE. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN OPERATIVE SIDE.

  Patient problems: Not Applicable

  MAUDE report 7704622 ↗