NA 1294-35-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295025955), received between Jul 10, 2017 and Aug 7, 2026 — classified as 48 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Loss of or Failure to Bond

  (b)(6) first report of retrievals for Statement of Work 10 for Q2 of 2026. (b)(6) is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to unspecified loosening and instability. The non-articular surface of the cemented CC femoral component shows moderate cement remaining. The non-articular surface of the cemented tibial tray shows abundant cement remaining.

  Patient problems: Joint Laxity

  MAUDE report 50178796 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION, THE HING SYSTEM WAS REMOVED ENTIRELY. THERE WAS NO ASEPTIC LOOSENING AND THE SYSTEM WAS WELL FIXED. AFTER REMOVING THE HINGE PIN AND POLYETHYLENE LINER THEY DISIMPACTED THE FEMORAL COMPONENT AND DISRUPTED THE TAPER ENGAGEMENT, LEAVING THE SLEEVE AND STEM BEHIND. AFTER REMOVING THE FEMUR THEY WORKED TO REMOVE FEMORAL SLEEVE AND DISTAL STEM AND MANAGED TO WITHOUT SUBSTANTIAL BONE LOSS. AFTER REMOVING THE FEMORAL COMPONENT THEY RESECTED BELOW THE TIBIAL COMPONENT AND KNOCKED IT LOOSE, REMOVING THE ENTIRE CONSTRUCT. AFTER THOROUGHLY WASHING OUT THE JOINT THEY PLACED A CEMENT SPACER TO LET THE INFECTION SUBSIDE. THE CASE TOOK APPROXIMATELY 90 MINUETS AND THERE WAS NO HARM DONE TO THE PT. ALL AVAILABLE INFORMATION WAS DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI:(B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23001221 ↗
• MalfunctionNov 5, 2024Migration; Migration

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL RADIOGRAPHIC EVALUATION DEVICE (RELATEDNESS): DEFINITELY PROCEDURE (RELATEDNESS): NOT RELATED DATE OF EVENT: 16/OCT/2024 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT DATE OF IMPLANT: NO INFORMATION PROVIDED TREATMENT/IMPACT: NO INFORMATION PROVIDED DEPUY SYNTHES PRODUCTS USED: PRODUCT DETAILS CATALOG ID: 960101 LOT ID: 2707895 COMPONENT TYPE: PATELLAR DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 35MM CATALOG ID: 129453226 LOT ID: 130996 COMPONENT TYPE: SLEEVE DESCRIPTION: UNIVERSAL FEM SLEEVE FULLY POROCOAT. CATALOG ID: 129454100 LOT ID: 130610 COMPONENT TYPE: SLEEVE DESCRIPTION: MBT REVISION TIBIAL SLEEVE 37MM CATALOG ID: 960861 LOT ID: 112161 COMPONENT TYPE: WEDGE DESCRIPTION: SIGMA WDG DISTAL 4MM SZ 3 RT CATALOG ID: 960866 LOT ID: 112174 COMPONENT TYPE: FEMWDG DESCRIPTION: SIGMA WDG POSTERIOR 4MM SZ 3 CATALOG ID: 960783 LOT ID: E73HM1 COMPONENT TYPE: ADAPTER DESCRIPTION: SIGMA FEMORAL ADAPTER BOLT NEUTRAL CATALOG ID: 960781 LOT ID: 130241 COMPONENT TYPE: ADAPTER DESCRIPTION: SIGMA FEMORAL ADAPTER 5 DEGREE CATALOG ID: 960088 LOT ID: 109047 COMPONENT TYPE: FEMORAL DESCRIPTION: SIGM

  Patient problems: Fall; Swelling/ Edema

  MAUDE report 20613791 ↗
• InjurySep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Pain

  MAUDE report 20279441 ↗
• InjurySep 17, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: Insufficient Information

  MAUDE report 20235492 ↗
• InjuryApr 10, 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 PAINFUL TKA. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain

  MAUDE report 19082436 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FIRST STAGE REVISION FOR INFECTION. TC3 IMPLANTS INSITU WHICH WERE REMOVED AND A CEMENT SPACER REPLACED. REVISION WILL BE BOOKED ONCE INFECTION CLEARS. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18785450 ↗
• InjuryNov 22, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: THE TIBIAL TRAY 129435125 MBT REVISION CEM TIB TRAY S2.5 WAS IMPLANTED ON (B)(6) 2023 (B)(6) 2023 WAS A SUNDAY, THE DATE OF THE PATIENT'S ADMISSION TO THE CLINIC, AND THE SURGEON HAS SURGERIES ONLY ON MONDAYS) AND REVISED ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 18191534 ↗
• InjurySep 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  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: Insufficient Information

  MAUDE report 17781411 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17539886 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TORN MCL AND PCL AND INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: THICKER IMPLANT REQUIRED WITH AUGMENTATION.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17224181 ↗
• InjuryMay 16, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES IN TODAY FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSSED REVISION SURGERY WITH DOCTOR. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16940741 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INFECTION. ALL COMPONENTS REMOVED AND ANTIBIOTIC CEMENT SPACERS WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. BONE CEMENT WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14213426 ↗
• InjuryFeb 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  AMPUTATION THE PATIENT RECEIVED AN ABOVE THE KNEE AMPUTATION DUE TO SIGNIFICANT PAIN, INFECTION, SWELLING, DRAINING, LYMPHEDEMA AND INABILITY TO AMBULATE. UPON ENTERING THE JOINT, THE CONSTRUCT WAS NOTED TO BE GROSSLY LOOSE AND INFECTED. THE AMPUTATION WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017, DOR: (B)(6) 2021, UNKNOWN KNEE. THIS COMPLAINT IS ALSO LINKED TO (B)(4) WHERE THE TIBIAL TRIAL WAS REPORTED. ANOTHER PC IS LINKED TO THIS COMPLAINT UNDER (B)(4) WHERE THE EVENT HAPPENED IN BETWEEN APR 2017 - MAR 2019.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13549610 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION TKA AFTER AN INFECTION WITH A TC3 IMPLANTS PLACED ON (B)(6) 2020. SHE WAS RETURNED TO SURGERY TODAY DUE TO A REPEAT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. ADDITIONAL PART USED AND REMOVED, NOT RETURNED 960784/J38U33 960861/HK5168 962343/HU0956 DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043484 ↗
• InjuryNov 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  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: Insufficient Information

  MAUDE report 12758548 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND HETEROTOPIC BONE FORMATION. DOI: UNKNOWN; DOR: (B)(6) 2021; (RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 12480969 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE KNEE BECAUSE THE PATIENT COMPLAINED OF SHIN PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12414325 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER LEFT KNEE REVISED 2007 TC3 RP CONSTRUCT. NO OR RECORD , THE EXACT DATE AND LOCATION ARE UNKNOWN EITHER. THIS PATIENT CAME INTO THE ER WITH AN INFECTED KNEE. I DO NOT HAVE LABS OR REPORTS TO CONFIRM THE INFECTION, I AM REPORTING WHAT THE SURGEON TOLD ME. SURGEON DID A THOROUGH I&D, DURING THE PROCEDURE THE PATELLA AND THE TIBIAL COMPONENT WERE LOOSE AT BONE TO CEMENT INTERFACE AND WERE EXPLANTED. UNKNOWN BONE CEMENT WAS USED. THE TC3 RP INSERT WAS ALSO EXPLANTED. THE FEMORAL COMPONENT WAS STILL WELL FIXED AND WAS LEFT IN SITU. THE PATIENT TOLD THE SURGEON PA THAT HER KNEE HAS HURT FOR THE LAST 2-3 YEARS. THE PATIENT ALSO HAD A SINUS TRACK OF PUSS ON THE BACK OF HER CALF THAT ORIGINATED FROM THE TIBIA. THIS KNEE WAS OBVIOUSLY INFECTED FOR A LONG TIME AND THE PATIENTS BONE QUALITY WAS TERRIBLE. SURGEON CEMENTED A TC3 RP INSERT IN THE TIBIA WITH ANTIBIOTIC CEMENT, SURGEON DID NOT WANT TO CEMENT ANOTHER METAL BASE PLATE IN WHILE THERE IS AN ACTIVE INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2007. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12370321 ↗
• 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 12363718 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT THE PATIENT WAS REVISED IN 2018 WITH A THICKER POLY (THICKEST AVAILABLE). PATIENT COMPLAINING OF PAIN IN KNEE AND NOT FEELING STABLE. SURGEON OPTED FOR SURGERY TO REVISE TIBIA, REMOVING TRAY STEM AND SLEEVE. REPLACED WITH A THICK TRAY, BIGGER SLEEVE, STEM AND NEW POLY TO GAIN BETTER BALANCE. SURGERY WAS SUCCESSFUL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12338563 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CR SIGMA TKA AND MULTIPLE FIBROTIC THERAPIES PERFORMED. A REVISION TO A TC3 RP ON (B)(6) WAS DONE. THERE WAS SUSPECTED LOOSENING OF THE TC3 RP CONSTRUCT AND LACK OF EXTENSION. THE TIBIA WAS NOT GROSSLY LOOSE. THE IMPLANTS WERE REMOVED AND A RECUT WAS DONE TO ALLOW FULL EXTENSION. A NEW MBT TRAY WAS IMPLANTED AND THERE WAS FULL EXTENSION. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12084911 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE KNEE WAS OPENED AND THE OLD SROM HINGED COMPONENTS REMOVED AND THESE WERE REPLACED WITH AN ATTUNE REVISION TRAY (AS FULLY POROCOATED TIB SLEEVES ARE AVAILABLE) A CROSSOVER ATTUNE LPS BEARING UTILIZED (AVAILABLE ON SAS) AND A FRESH S ROM HINGE IMPLANTED, ALONG WITH A NEW PATELLA COMPONENT. REMOVAL OF ALL COMPONENTS DUE TO FUNGAL INFECTION.

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

  MAUDE report 11705679 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A SIGMA TOTAL KNEE DONE ON (B)(6) 2019 AND A REVISION OF TIBIAL COMPONENT ON (B)(6) 2020 (NO DER RECORD IN THE SYSTEM). THE PATIENT COMPLAINT OF PAIN AND INSTABILITY WITH KNEE "GIVING OUT". THE FEMORAL AND THE TIBIAL COMPONENTS WERE REMOVED AND AN ATTUNE REVISION WAS PERFORMED. DOI: (B)(6) 2019, 1ST REVISION: (B)(6) 2020 (TIBIAL COMPONENT), 2ND REVISION: (B)(6) 2021 (FEMORAL AND TIBIAL COMPONENTS), LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11680492 ↗
• InjuryDec 1, 2020Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY AND TIBIAL IMPLANT MIGRATION/LOOSENING. DATE OF IMPLANTATION: (B)(6) 2013, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF THE TIBIAL CONSTRUCT AND INSERT.

  Patient problems: Joint Laxity

  MAUDE report 10928289 ↗