NA 1294-35-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295025948), received between Aug 30, 2017 and Aug 26, 2026 — classified as 36 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Loss of or Failure to Bond

  It was reported that the patient was revised due to loose tibia.Affected side: Right Knee.

  Patient problems: Insufficient Information

  MAUDE report 50454898 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIAL COMPONENTS WERE REVISED FOR LOOSENING SECONDARY TO FRACTURE. TIBIA WAS LOOSE AT BONE TO CEMENT INTERFACE. CEMENT USED WAS FROM COMPETITOR BRAND. NO X-RAYS AVAILABLE. ALL KNOWN INFORMATION DISCLOSED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25058676 ↗
• InjuryDec 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT TIBIAL TRAY WAS LOOSE. ACTIVITY LEVEL - YES, DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23705779 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA FOR OA ON THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY AND THE TIBIAL TRAY WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2025, THE PATIENT WAS IN PAIN AND WAS EXAMINED, WHICH REVEALED A SUSPECTED INFECTION. IMPLANT REMOVAL IS PLANNED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23015546 ↗
• InjuryMay 14, 2025Migration; 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: (B)(6) 2020. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22018245 ↗
• InjuryFeb 24, 2025Noise, Audible; Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED ON A CALL LAST (B)(6) 2025, THE PATIENT HAD A ROD PLACED AND A REVISION OF THE KNEE WAS PERFORMED DUE TO LOWER FEMUR FRACTURE (SHATTERED) ON (B)(6) 2025. SINCE THAT TIME, THE PATIENT HAS HAD MULTIPLE "PARTIAL DISLOCATIONS" WHERE THE KNEE FEELS LIKE IT POPS OUT AND THEN HAS TO BE PUSHED BACK INTO PLACE. THE PATIENT HAS BEEN EXPERIENCING SEVERE PAIN DURING THOSE EPISODES.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21444908 ↗
• InjurySep 27, 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20323027 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: OTHER PAIN.

  Patient problems: Pain

  MAUDE report 18967839 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE EXPLANT WAS PERFORMED DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2014. DOR: (B)(6) 2022 AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15983787 ↗
• InjuryDec 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  FEMALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT LOOSENING OF THE TIBIAL CONSTRUCT SECONDARY TO THE CEMENT COMING INTO CONTACT WITH THE TIBIAL SLEEVE PREVENTING APPROPRIATE BONE INGROWTH WITH THE POROUS SURFACE. THERE WAS SIGNIFICANT TIBIAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: 2013. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15958356 ↗
• InjuryDec 7, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT HAS RHUEMABID ARTHRITIS HAD 80+ PREVIOUS SURGERIES. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15932783 ↗
• 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.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15925500 ↗
• 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 13925413 ↗
• InjuryNov 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12780767 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719488 ↗
• 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 12357963 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE BECAME INFECTED FOLLOWING THIS SURGERY ON (B)(6) 2021. THE DOCTOR DECIDED TO REMOVE ALL THE COMPONENTS DO TO THIS INFECTION. IT WAS ALSO REPORTED THAT A FEMORAL IMPACTOR TIP BROKE OFF DURING THIS SURGERY. A COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11754202 ↗
• 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 11091373 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION. DATE OF PRIMARY: (B)(6) 2008 (NON-DEPUY PRODUCTS IMPLANTED). DATE OF REVISION #1: (B)(6) 2010 (INSTABILITY - FEMUR, TIBIAL TRAY, TIBIAL INSERT). DATE OF REVISION #2: (B)(6) 2012 (INFECTION - FEMUR, TIBIAL TRAY, TIBIAL INSERT, COMPETITOR PATELLA 12 IPS CAPTURED ON (B)(4))). DATE OF REVISION #3: (B)(6) 2013 (12 IPS CAPTURED ON (B)(4)) (RIGHT KNEE). TREATMENT: REVISION OF FEMUR CONSTRUCT, TIBIAL TRAY CONSTRUCT, PATELLA, AND TIBIAL INSERT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10836983 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. INSERT WAS CHANGED ON (B)(6) 2020. DOI: (B)(6) 2019; (B)(6) 2020 (INSERT ONLY), DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10304683 ↗
• 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 10283401 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INSTABILITY IN FLEXION AND EXTENSION. ALL SIGMA REVISION COMPONENTS WERE REMOVED AND AN ATTUNE KNEE REVISION WAS PUT IN. DOI: (B)(6) 2012, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10191048 ↗
• InjuryJun 11, 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 10143556 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED WITH A KNEE REPLACEMENT ON THE (B)(6) 2019. PATIENT WAS ADMITTED TO HOSPITAL DUE TO AN INFLAMMATION IN THE KNEE. REVISION SURGERY PLANNED FOR THE (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation; No Code Available

  MAUDE report 10014830 ↗
• InjuryApr 8, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE FOR THE PATIENT¿S RIGHT KNEE JOINT. THE 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 (THIS EVENT WAS REPORTED AS (B)(4)). THE 2ND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE TIBIAL TRAY (P/N: 129435120), THE TIBIAL SLEEVE (P/N: 129454000), THE TIBIAL STEM (P/N: 866424) AND THE TIBIAL INSERT (P/N: 962332) DUE TO THE SINKING AND TILTING OF THE TIBIAL COMPONENT. THE SURGERY WAS COMPLETED, AND IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9939422 ↗