NA 1294-54-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10603295026419), received between Jul 10, 2017 and Apr 24, 2026 — classified as 67 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 68 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEPTIC A LOOSENING. IT WAS STATED THAT FEMUR/TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24981876 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  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 23992688 ↗
• InjuryAug 11, 2025Loss of or Failure to Bond; Degraded; Loss of or Failure to Bond; Degraded

  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: SIGMA FEMORAL STEM, SLEEVE, AND COMPONENT AS WELL AS THE TIBIAL SLEEVE, TIBIAL STEM, AND TIBIAL TRAY WERE REVISED FOR LOOSENING AT UNKNOWN INTERFACE. THE TRUNNION OF THE TIBIAL STEM SHOWS MINOR FRETTING. THE TIBIAL SLEEVE SHOWS MINOR CORROSION.

  Patient problems: Insufficient Information

  MAUDE report 22769548 ↗
• InjuryAug 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TC3 TIBIA W/ STEM AND SLEEVE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT¿S KNEE BECAME SEPTIC AND TIBIAL CONSTRUCT BECAME LOOSE. THE FEMUR, TIBIAL CONSTRUCT, POLY, AND PATELLA WERE EXTRACTED. PATELLA WAS NOT LISTED IN THE LIST OF IMPLANTS FROM INITIAL SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22687559 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) 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 TIBIAL SLEEVE, TIBIAL STEM, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED FOR INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22668254 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTED LEFT DISTAL FEMORAL REPLACEMENT. REMOVED CERTAIN IMPLANTS AND PERFORMED WASHOUT AND I&D. REPLACED CERTAIN IMPLANTS ALONG WITH SOME ANTIBIOTIC CEMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21549870 ↗
• MalfunctionNov 5, 2024Migration; Migration

  SUBJECT ID: (B)(4). 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: SIG

  Patient problems: Fall; Swelling/ Edema

  MAUDE report 20611621 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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; Pain

  MAUDE report 20279438 ↗
• 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 18184813 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE IMPLANTS WERE EXPLANTED DUE TO NICKEL ALLERGY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17611807 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214052 ↗
• 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 15983793 ↗
• InjuryDec 9, 2022Osseointegration Problem; Osseointegration Problem

  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: Inadequate Osseointegration

  MAUDE report 15952364 ↗
• InjuryMay 20, 2022Osseointegration Problem; Osseointegration Problem

  REVISION LEFT TOTAL KNEE FOR LOOSE TIBIAL COMPONENT. IT IS UNDERSTOOD PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE IN NATIVE KNEE PRIOR TO COMPLEX PRIMARY TOTAL KNEE REPLACEMENT. TIBIAL COMPONENT METAPHYSEAL SLEEVE AND TIBIAL STEM LOOSE THUS REMOVED AND REVISED. NATIVE PATELLA RESURFACED AT TIME OF REVISION. PRIMARY 31.5.18 DOI: (B)(6), 2018. DOR: (B)(6), 2022. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14453345 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS REVISION BECAUSE OF PAIN AND STIFFNESS - REVISED TO A HINGE FROM ANOTHER COMPANY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13769523 ↗
• 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 (B)(4). DOI: (B)(6) 2020, DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 13043436 ↗
• InjuryNov 10, 2021Migration; Migration

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL TRAY AT THE UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE TIBIAL STEM MIGRATED. DOI: (B)(6) 2015, DOR: (B)(6) 2021, UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12788826 ↗
• 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 12719707 ↗
• 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 12719528 ↗
• 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 12414321 ↗
• 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 12338581 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WAS THE CEMENT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PRODUCT AND LOT NUMBERS. NO, PALACOS CEMENT WAS USED IN THE PREVIOUS OPERATION. 2. IT WAS MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD A REVISION OF HER RIGHT KNEE BY MR (B)(6) AT THE (B)(6) HOSPITAL ON THE (B)(6) 2019. DID THIS REVISION INVOLVE EXPLANTATION OF DEPUY PRODUCTS? IF SO, WAS THIS REVISION REPORTED? (IF THIS REVISION HAS BEEN PREVIOUSLY REPORTED PLEASE PROVIDE THE PC # IF KNOWN). NO, IT WAS A COMPETITOR KNEE REPLACEMENT THAT WAS REVISED. 3. IT WAS INDICATED THAT LOOSENING WAS DUE TO INFECTION. CAN YOU PLEASE ADVISE THE LOOSENING COMPONENT/S AND LOOSENING INTERFACE? THE FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE BONE CEMENT INTERFACE AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA, THERE WAS ALSO SOME LOOSENING AROUND THE FEMORAL SLEEVE. 4. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12235697 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. CONVERT TO ANTIBIOTIC SPACER. A DEPUY CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11820238 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POSSIBLE ROTATION OF IMPLANTS. NO LOOSENING WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11804825 ↗
• 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 11754216 ↗