NA 1294-54-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295026426), received between Dec 21, 2017 and Aug 26, 2026 — classified as 41 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 41 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 50454557 ↗
• 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 22999882 ↗
• InjuryApr 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POSSIBLE ASEPTIC LOOSENING. REMOVED ALL IMPLANTS AND CONVERTED TO ATTUNE REVISION KNEE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892737 ↗
• InjuryJan 17, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. THE LOOSENING WAS AT THE NON-CEMENTED INTERFACE. DEPUY CEMENT WAS USED. DOI: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21181154 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: PLEASE CONFIRM WHAT IMPLANTS WERE MISPOSITIONED. ¿ FEMORAL COMPONENT AND TIBIAL TRAY. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, DUE TO THE MISPOSITIONING OF THE IMPLANTS. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, ALL CORRECT SIZING. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, REPORTED AS OKAY. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Joint Laxity

  MAUDE report 19261608 ↗
• 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 19082440 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DOI: UNKNOWN . DOR: JAN 17, 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18570282 ↗
• InjuryDec 22, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH KNEE PAIN. THERE WAS NO INDICATION OF ANY INFECTION. SURGEON OPENED UP KNEE AND FOUND TIBIA AND TIBIAL SLEEVE WERE LOOSE. SURGEON REMOVED TIBIA AND SLEEVE CONSTRUCT AND REMOVED FEMUR FOR BETTER KNEE ACCESS. SURGEON LEFT FEMORAL STEM AND SLEEVE AS IT WAS WELL FIXED. SURGEON OPTED TO RE IMPLANT DJO CONE AND NEW TC3 FEMUR AND MBT TRAY AND CEMENTED STEM. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18382945 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. NO DELAY. DOI- (B)(6) 2020; DOR- (B)(6) 2023; AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18119147 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAS A LEFT TOTAL SIGMA KNEE WITH A LOOSE TIBIAL TRAY. THE SURGEON REVISED THE TIBIAL TRAY AND RETAINED THE WELL FIXED FEMUR AND PATELLA. THE TIBIAL SLEEVE DID NOT SEEM TO INGROW ON THE CONSTRUCT. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18096648 ↗
• InjuryAug 4, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR AND HAS HAD ONGOING ISSUES SINCE WITH PAIN, SWELLING AND LOOSENING. PATIENT HAD A PARTIAL REVISION FOR PAIN AND LOOSENING. PATIENT PRESENTED AGAIN WITH PAIN AND BONE SCANS SUGGESTING LOOSENING. REVISED ENTIRE CONSTRUCT. PRESENTED AGAIN WITH PAIN. BONE SCAN SUGGESTED LOOSENING SO REVISED TO ATTUNE REVISION WITH STEMS AND SLEEVES. IMPLANTS WEREN'T GROSSLY LOOSE AND REQUIRED SOME WORK (FLEXIBLE OSTEOTOMES AROUND METAPHYSEAL SLEEVES AND SLAP HAMMER ATTACHMENTS) TO REMOVE. DOI: (B)(6) 2017 DOE: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 17459459 ↗
• 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 (B)(6) AND REVISION IN (B)(6). SHE HAD A LEFT TOTAL KNEE IN (B)(6), A REVISION IN (B)(6) AND A SCOPE DEBRIDEMENT IN (B)(6). 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 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 16940750 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584641 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A PAINFUL KNEE AND SCANS SHOWED THE IMPLANT WAS LOOSE BOTH THE FEMUR AND THE TIBIA AND THE PATIENT WAS EXPERIENCING INSTABILITY. NO INFECTION WAS FOUND. DOI: (B)(6) 2019. DOR: (B)(6) 2022. LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14985774 ↗
• 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 12363720 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION NOT SURE SORRY. B. LOT NUMBER: UNIVERSAL STEM 115X14MM FLUTED (867428) AND LPS XX-SM HINGE PIN. REFER IMAGE UPLOADED. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. NO STYKER.

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

  MAUDE report 11796229 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE TOTAL REVISION DUE TO MULTIPLE ISSUES INVOLVING AN UNKNOWN MANUFACTURER KNEE SYSTEM. DEPUY PRODUCTS AND CEMENT WERE USED DURING THE OPERATION. THE SURGEON NOTED WHILE IMPLANTING THE TIBIAL COMPONENT THE CREATION OF A SMALL CRACK ANTERIOR MEDIAL IN THE TIBIA. IT WAS LESS THAN A MILLIMETER. IT WAS EXTREMELY STABLE AND DID NOT REQUIRE FIXATION OR INTERVENTION. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF RIGHT TOTAL KNEE IMPLANTS, ALL COMPONENTS, COMPLETE SYNOVECTOMY AND AGGRESSIVE DEBRIDEMENT, AND PLACEMENT OF TEMPORARY ANTIBIOTIC LOADED SPACER CONTAINING GENTAMICIN AND VANCOMYCIN ANTIBIOTIC TO ADDRESS RECURRENT INFECTION. THE SURGEON NOTED THE REMOVAL OF FIBROUS TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11686812 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED FOR AN EVALUATION DUE TO RIGHT KNEE PAIN, SWELLING, SYNOVITIS, AND WARMTH. THE PHYSICIAN NOTED THE ASPIRATION OF 10 ML OF CLOUDY SLIGHTLY BROWNISH FLUID. THE PHYSICIAN INDICATED THE FLUID WOULD BE SENT OFF FOR CULTURES AND CELL COUNT. IT WAS ALSO NOTED THE PATIENT WOULD HAVE BLOOD WORK COMPLETED. THE PHYSICIAN INDICATED THE PATIENT WAS ON ORAL SUPPRESSION WITH DOXYCYCLINE.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 11516463 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019 , DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11455846 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11398472 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGES ON (B)(6) 2017 AND (B)(6) 2020 BOTH HAVE SEPARATE MDR. ALSO A PATELLA WAS REMOVED UNKNOWN LOT AND REFERENCE OR IF IT WAS DEPUY. DOI: (B)(6) 2017, (B)(6) 2020 (INSERT); DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11292409 ↗
• 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 10836992 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS REVISION DUE TO LOOSENING, INFECTION AND FRACTURE (LOOSENING AND FRACTURE ARE UNSPECIFIED). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10726872 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL TKA WAS AN INTERMEDICS DONE IN (B)(6) CITY.

  Patient problems: Adhesion(s); Discomfort; Edema; No Code Available; Pain

  MAUDE report 10646438 ↗
• InjurySep 29, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION OF UNKNOWN MANUFACTURER PRODUCTS DUE TO FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH ASEPTIC LOOSENING FEMORAL COMPONENT. ALL COMPONENTS WERE REVISED WITH THE EXCEPTION OF THE UNKNOWN MANUFACTURER PATELLAR COMPONENT. DEPUY PFC SIGMA PRODUCTS ALONG WITH DEPUY CEMENT WAS USED DURING THE REVISION. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, EFFUSION, PAIN, DISCOMFORT, FEMORAL COMPONENT MIGRATION AND LOOSENING AT AN UNKNOWN INTERFACE, TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE, AND NO INGROWTH OF THE TIBIAL OR FEMORAL SLEEVES. THE UNKNOWN MANUFACTURER PATELLAR COMPONENT WAS RETAINED. ALL OTHER COMPONENTS WERE REVISED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

  Patient problems: Discomfort; Edema; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10600444 ↗